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Zepbound
tirzepatide · Injection, Solution
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Tirzepatide | 10 mg/.5mL | 2601743 | View |
| Tirzepatide | 12.5 mg/.5mL | 2601743 | View |
| Tirzepatide | 12.5 mg/mL | 2601743 | View |
| Tirzepatide | 15 mg/.5mL | 2601743 | View |
| Tirzepatide | 16.7 mg/mL | 2601743 | View |
| Tirzepatide | 2.5 mg/.5mL | 2601743 | View |
| Tirzepatide | 20.8 mg/mL | 2601743 | View |
| Tirzepatide | 25 mg/mL | 2601743 | View |
| Tirzepatide | 4.17 mg/mL | 2601743 | View |
| Tirzepatide | 5 mg/.5mL | 2601743 | View |
| Tirzepatide | 7.5 mg/.5mL | 2601743 | View |
| Tirzepatide | 8.33 mg/mL | 2601743 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| G-Protein-linked Receptor Interactions [MoA] | MoA | 2 members — no class page |
| GLP-1 Receptor Agonist [EPC] | EPC | All 15 members |
| Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] | MoA | All 15 members |
| Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC] | EPC | 2 members — no class page |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 217806-001 | ZEPBOUND (AUTOINJECTOR) | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-002 | ZEPBOUND (AUTOINJECTOR) | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-003 | ZEPBOUND (AUTOINJECTOR) | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-004 | ZEPBOUND (AUTOINJECTOR) | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-005 | ZEPBOUND (AUTOINJECTOR) | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-006 | ZEPBOUND (AUTOINJECTOR) | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-007 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-008 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-009 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-010 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-011 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-012 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-013 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-014 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-015 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-016 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-017 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-018 | ZEPBOUND | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-019 | ZEPBOUND KWIKPEN | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-020 | ZEPBOUND KWIKPEN | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-021 | ZEPBOUND KWIKPEN | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-022 | ZEPBOUND KWIKPEN | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-023 | ZEPBOUND KWIKPEN | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS | |
| 217806-024 | ZEPBOUND KWIKPEN | SOLUTION | TIRZEPATIDE | Prescription | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 9474780 | May 13, 2036 | 001 | Yes | December 7, 2023 | |
| 9474780 | May 13, 2036 | 002 | Yes | December 7, 2023 | |
| 9474780 | May 13, 2036 | 003 | Yes | December 7, 2023 | |
| 9474780 | May 13, 2036 | 004 | Yes | December 7, 2023 | |
| 9474780 | May 13, 2036 | 005 | Yes | December 7, 2023 | |
| 9474780 | May 13, 2036 | 006 | Yes | December 7, 2023 | |
| 9474780 | May 13, 2036 | 007 | Yes | April 18, 2024 | |
| 9474780 | May 13, 2036 | 008 | Yes | April 18, 2024 | |
| 9474780 | May 13, 2036 | 009 | Yes | April 18, 2024 | |
| 9474780 | May 13, 2036 | 010 | Yes | April 18, 2024 | |
| 9474780 | May 13, 2036 | 011 | Yes | April 18, 2024 | |
| 9474780 | May 13, 2036 | 012 | Yes | April 18, 2024 | |
| 9474780 | May 13, 2036 | 013 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 014 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 015 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 016 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 017 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 018 | Yes | February 20, 2026 | |
| 9474780 | May 13, 2036 | 019 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 020 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 021 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 022 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 023 | Yes | February 5, 2026 | |
| 9474780 | May 13, 2036 | 024 | Yes | February 20, 2026 | |
| 11918623 | June 14, 2039 | 001 | No | U-3855 | March 28, 2024 |
| 12629404 | June 14, 2039 | 001 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 001 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 001 | No | December 7, 2023 | |
| 12453756 | June 14, 2039 | 001 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 002 | No | U-3855 | March 28, 2024 |
| 12629404 | June 14, 2039 | 002 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 002 | No | U-4532 | June 5, 2026 |
| 12453756 | June 14, 2039 | 002 | No | November 17, 2025 | |
| 11357820 | June 14, 2039 | 002 | No | December 7, 2023 | |
| 11918623 | June 14, 2039 | 003 | No | U-3855 | March 28, 2024 |
| 12629404 | June 14, 2039 | 003 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 003 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 003 | No | December 7, 2023 | |
| 12453756 | June 14, 2039 | 003 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 004 | No | U-3855 | March 28, 2024 |
| 12629404 | June 14, 2039 | 004 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 004 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 004 | No | December 7, 2023 | |
| 12453756 | June 14, 2039 | 004 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 005 | No | U-3855 | March 28, 2024 |
| 12629404 | June 14, 2039 | 005 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 005 | No | U-4532 | June 5, 2026 |
| 12453756 | June 14, 2039 | 005 | No | November 17, 2025 | |
| 11357820 | June 14, 2039 | 005 | No | December 7, 2023 | |
| 11918623 | June 14, 2039 | 006 | No | U-3855 | March 28, 2024 |
| 12629404 | June 14, 2039 | 006 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 006 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 006 | No | December 7, 2023 | |
| 12453756 | June 14, 2039 | 006 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 007 | No | U-3855 | April 18, 2024 |
| 12629404 | June 14, 2039 | 007 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 007 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 007 | No | April 18, 2024 | |
| 12453756 | June 14, 2039 | 007 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 008 | No | U-3855 | April 18, 2024 |
| 12629404 | June 14, 2039 | 008 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 008 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 008 | No | April 18, 2024 | |
| 12453756 | June 14, 2039 | 008 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 009 | No | U-3855 | April 18, 2024 |
| 12629404 | June 14, 2039 | 009 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 009 | No | U-4532 | June 5, 2026 |
| 12453756 | June 14, 2039 | 009 | No | November 17, 2025 | |
| 11357820 | June 14, 2039 | 009 | No | April 18, 2024 | |
| 11918623 | June 14, 2039 | 010 | No | U-3855 | April 18, 2024 |
| 12629404 | June 14, 2039 | 010 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 010 | No | U-4532 | June 5, 2026 |
| 11357820 | June 14, 2039 | 010 | No | April 18, 2024 | |
| 12453756 | June 14, 2039 | 010 | No | November 17, 2025 | |
| 11918623 | June 14, 2039 | 011 | No | U-3855 | April 18, 2024 |
| 12629404 | June 14, 2039 | 011 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 011 | No | U-4532 | June 5, 2026 |
| 12453756 | June 14, 2039 | 011 | No | November 17, 2025 | |
| 11357820 | June 14, 2039 | 011 | No | April 18, 2024 | |
| 11918623 | June 14, 2039 | 012 | No | U-3855 | April 18, 2024 |
| 12629404 | June 14, 2039 | 012 | No | U-4531 | June 5, 2026 |
| 12629404 | June 14, 2039 | 012 | No | U-4532 | June 5, 2026 |
| 12453756 | June 14, 2039 | 012 | No | November 17, 2025 | |
| 11357820 | June 14, 2039 | 012 | No | April 18, 2024 | |
| 12343382 | July 22, 2039 | 001 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 001 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 001 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 001 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 001 | No | U-4308 | November 17, 2025 |
| 12453758 | July 22, 2039 | 001 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 001 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 001 | No | U-4309 | November 17, 2025 |
| 12616740 | July 22, 2039 | 001 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 001 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 001 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 002 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 002 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 002 | No | U-4410 | July 25, 2025 |
| 12343382 | July 22, 2039 | 002 | No | U-4409 | July 25, 2025 |
| 12453758 | July 22, 2039 | 002 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 002 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 002 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 002 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 002 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 002 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 002 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 003 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 003 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 003 | No | U-4410 | July 25, 2025 |
| 12343382 | July 22, 2039 | 003 | No | U-4409 | July 25, 2025 |
| 12453758 | July 22, 2039 | 003 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 003 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 003 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 003 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 003 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 003 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 003 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 004 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 004 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 004 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 004 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 004 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 004 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 004 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 004 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 004 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 004 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 004 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 005 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 005 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 005 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 005 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 005 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 005 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 005 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 005 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 005 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 005 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 005 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 006 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 006 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 006 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 006 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 006 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 006 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 006 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 006 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 006 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 006 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 006 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 007 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 007 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 007 | No | U-4410 | July 25, 2025 |
| 12343382 | July 22, 2039 | 007 | No | U-4409 | July 25, 2025 |
| 12453758 | July 22, 2039 | 007 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 007 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 007 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 007 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 007 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 007 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 007 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 008 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 008 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 008 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 008 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 008 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 008 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 008 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 008 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 008 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 008 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 008 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 009 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 009 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 009 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 009 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 009 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 009 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 009 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 009 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 009 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 009 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 009 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 010 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 010 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 010 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 010 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 010 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 010 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 010 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 010 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 010 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 010 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 010 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 011 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 011 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 011 | No | U-4409 | July 25, 2025 |
| 12343382 | July 22, 2039 | 011 | No | U-4410 | July 25, 2025 |
| 12453758 | July 22, 2039 | 011 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 011 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 011 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 011 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 011 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 011 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 011 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 012 | No | U-4227 | July 25, 2025 |
| 12343382 | July 22, 2039 | 012 | No | U-4228 | July 25, 2025 |
| 12343382 | July 22, 2039 | 012 | No | U-4410 | July 25, 2025 |
| 12343382 | July 22, 2039 | 012 | No | U-4409 | July 25, 2025 |
| 12453758 | July 22, 2039 | 012 | No | U-4311 | November 17, 2025 |
| 12453758 | July 22, 2039 | 012 | No | U-4310 | November 17, 2025 |
| 12453758 | July 22, 2039 | 012 | No | U-4309 | November 17, 2025 |
| 12453758 | July 22, 2039 | 012 | No | U-4308 | November 17, 2025 |
| 12616740 | July 22, 2039 | 012 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 012 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 012 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 013 | No | U-4409 | February 5, 2026 |
| 12343382 | July 22, 2039 | 013 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 013 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 013 | No | U-4410 | February 5, 2026 |
| 12453758 | July 22, 2039 | 013 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 013 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 013 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 013 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 013 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 013 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 013 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 014 | No | U-4409 | February 5, 2026 |
| 12343382 | July 22, 2039 | 014 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 014 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 014 | No | U-4410 | February 5, 2026 |
| 12453758 | July 22, 2039 | 014 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 014 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 014 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 014 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 014 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 014 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 014 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 015 | No | U-4409 | February 5, 2026 |
| 12343382 | July 22, 2039 | 015 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 015 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 015 | No | U-4410 | February 5, 2026 |
| 12453758 | July 22, 2039 | 015 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 015 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 015 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 015 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 015 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 015 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 015 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 016 | No | U-4409 | February 5, 2026 |
| 12343382 | July 22, 2039 | 016 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 016 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 016 | No | U-4410 | February 5, 2026 |
| 12453758 | July 22, 2039 | 016 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 016 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 016 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 016 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 016 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 016 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 016 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 017 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 017 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 017 | No | U-4410 | February 5, 2026 |
| 12343382 | July 22, 2039 | 017 | No | U-4409 | February 5, 2026 |
| 12453758 | July 22, 2039 | 017 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 017 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 017 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 017 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 017 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 017 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 017 | No | U-4499 | May 5, 2026 |
| 12453758 | July 22, 2039 | 018 | No | U-4308 | February 20, 2026 |
| 12453758 | July 22, 2039 | 018 | No | U-4311 | February 20, 2026 |
| 12453758 | July 22, 2039 | 018 | No | U-4310 | February 20, 2026 |
| 12453758 | July 22, 2039 | 018 | No | U-4309 | February 20, 2026 |
| 12343382 | July 22, 2039 | 018 | No | U-4227 | February 20, 2026 |
| 12343382 | July 22, 2039 | 018 | No | U-4410 | February 20, 2026 |
| 12343382 | July 22, 2039 | 018 | No | U-4409 | February 20, 2026 |
| 12343382 | July 22, 2039 | 018 | No | U-4228 | February 20, 2026 |
| 12616740 | July 22, 2039 | 018 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 018 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 018 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 019 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 019 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 019 | No | U-4410 | February 5, 2026 |
| 12343382 | July 22, 2039 | 019 | No | U-4409 | February 5, 2026 |
| 12453758 | July 22, 2039 | 019 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 019 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 019 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 019 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 019 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 019 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 019 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 020 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 020 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 020 | No | U-4410 | February 5, 2026 |
| 12343382 | July 22, 2039 | 020 | No | U-4409 | February 5, 2026 |
| 12453758 | July 22, 2039 | 020 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 020 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 020 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 020 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 020 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 020 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 020 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 021 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 021 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 021 | No | U-4410 | February 5, 2026 |
| 12343382 | July 22, 2039 | 021 | No | U-4409 | February 5, 2026 |
| 12453758 | July 22, 2039 | 021 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 021 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 021 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 021 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 021 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 021 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 021 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 022 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 022 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 022 | No | U-4410 | February 5, 2026 |
| 12343382 | July 22, 2039 | 022 | No | U-4409 | February 5, 2026 |
| 12453758 | July 22, 2039 | 022 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 022 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 022 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 022 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 022 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 022 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 022 | No | U-4499 | May 5, 2026 |
| 12343382 | July 22, 2039 | 023 | No | U-4228 | February 5, 2026 |
| 12343382 | July 22, 2039 | 023 | No | U-4227 | February 5, 2026 |
| 12343382 | July 22, 2039 | 023 | No | U-4410 | February 5, 2026 |
| 12343382 | July 22, 2039 | 023 | No | U-4409 | February 5, 2026 |
| 12453758 | July 22, 2039 | 023 | No | U-4309 | February 5, 2026 |
| 12453758 | July 22, 2039 | 023 | No | U-4308 | February 5, 2026 |
| 12453758 | July 22, 2039 | 023 | No | U-4310 | February 5, 2026 |
| 12453758 | July 22, 2039 | 023 | No | U-4311 | February 5, 2026 |
| 12616740 | July 22, 2039 | 023 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 023 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 023 | No | U-4499 | May 5, 2026 |
| 12453758 | July 22, 2039 | 024 | No | U-4311 | February 20, 2026 |
| 12453758 | July 22, 2039 | 024 | No | U-4310 | February 20, 2026 |
| 12453758 | July 22, 2039 | 024 | No | U-4309 | February 20, 2026 |
| 12453758 | July 22, 2039 | 024 | No | U-4308 | February 20, 2026 |
| 12343382 | July 22, 2039 | 024 | No | U-4410 | February 20, 2026 |
| 12343382 | July 22, 2039 | 024 | No | U-4409 | February 20, 2026 |
| 12343382 | July 22, 2039 | 024 | No | U-4228 | February 20, 2026 |
| 12343382 | July 22, 2039 | 024 | No | U-4227 | February 20, 2026 |
| 12616740 | July 22, 2039 | 024 | No | U-4497 | May 5, 2026 |
| 12616740 | July 22, 2039 | 024 | No | U-4498 | May 5, 2026 |
| 12616740 | July 22, 2039 | 024 | No | U-4499 | May 5, 2026 |
| Code | Expires | Product |
|---|---|---|
| NP | November 8, 2026 | 001 |
| NP | November 8, 2026 | 002 |
| NP | November 8, 2026 | 003 |
| NP | November 8, 2026 | 004 |
| NP | November 8, 2026 | 005 |
| NP | November 8, 2026 | 006 |
| NCE | May 13, 2027 | 001 |
| NCE | May 13, 2027 | 002 |
| NCE | May 13, 2027 | 003 |
| NCE | May 13, 2027 | 004 |
| NCE | May 13, 2027 | 005 |
| NCE | May 13, 2027 | 006 |
| NCE | May 13, 2027 | 007 |
| NCE | May 13, 2027 | 008 |
| NCE | May 13, 2027 | 009 |
| NCE | May 13, 2027 | 010 |
| NCE | May 13, 2027 | 011 |
| NCE | May 13, 2027 | 012 |
| NCE | May 13, 2027 | 013 |
| NCE | May 13, 2027 | 014 |
| NCE | May 13, 2027 | 015 |
| NCE | May 13, 2027 | 016 |
| NCE | May 13, 2027 | 017 |
| NCE | May 13, 2027 | 018 |
| NCE | May 13, 2027 | 019 |
| NCE | May 13, 2027 | 020 |
| NCE | May 13, 2027 | 021 |
| NCE | May 13, 2027 | 022 |
| NCE | May 13, 2027 | 023 |
| NCE | May 13, 2027 | 024 |
| M-82 | October 18, 2027 | 001 |
| M-82 | October 18, 2027 | 002 |
| M-82 | October 18, 2027 | 003 |
| M-82 | October 18, 2027 | 004 |
| M-82 | October 18, 2027 | 005 |
| M-82 | October 18, 2027 | 006 |
| M-82 | October 18, 2027 | 007 |
| M-82 | October 18, 2027 | 008 |
| M-82 | October 18, 2027 | 009 |
| M-82 | October 18, 2027 | 010 |
| M-82 | October 18, 2027 | 011 |
| M-82 | October 18, 2027 | 012 |
| M-82 | October 18, 2027 | 013 |
| M-82 | October 18, 2027 | 014 |
| M-82 | October 18, 2027 | 015 |
| M-82 | October 18, 2027 | 016 |
| M-82 | October 18, 2027 | 017 |
| M-82 | October 18, 2027 | 018 |
| M-82 | October 18, 2027 | 019 |
| M-82 | October 18, 2027 | 020 |
| M-82 | October 18, 2027 | 021 |
| M-82 | October 18, 2027 | 022 |
| M-82 | October 18, 2027 | 023 |
| M-82 | October 18, 2027 | 024 |
| I-958 | December 20, 2027 | 001 |
| I-958 | December 20, 2027 | 002 |
| I-958 | December 20, 2027 | 003 |
| I-958 | December 20, 2027 | 004 |
| I-958 | December 20, 2027 | 005 |
| I-958 | December 20, 2027 | 006 |
| I-958 | December 20, 2027 | 007 |
| I-958 | December 20, 2027 | 008 |
| I-958 | December 20, 2027 | 009 |
| I-958 | December 20, 2027 | 010 |
| I-958 | December 20, 2027 | 011 |
| I-958 | December 20, 2027 | 012 |
| I-958 | December 20, 2027 | 013 |
| I-958 | December 20, 2027 | 014 |
| I-958 | December 20, 2027 | 015 |
| I-958 | December 20, 2027 | 016 |
| I-958 | December 20, 2027 | 017 |
| I-958 | December 20, 2027 | 018 |
| I-958 | December 20, 2027 | 019 |
| I-958 | December 20, 2027 | 020 |
| I-958 | December 20, 2027 | 021 |
| I-958 | December 20, 2027 | 022 |
| I-958 | December 20, 2027 | 023 |
| I-958 | December 20, 2027 | 024 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 41 | Efficacy | Approved | August 26, 2026 | Standard |
| Supplement | 42 | Labeling | Approved | February 25, 2026 | Standard |
| Supplement | 2 | Labeling | Approved | January 20, 2026 | Standard |
| Supplement | 37 | Manufacturing (CMC) | Approved | January 7, 2026 | Standard |
| Supplement | 31 | Labeling | Approved | September 25, 2025 | Standard |
| Supplement | 20 | Labeling | Approved | February 7, 2025 | Standard |
| Supplement | 13 | Efficacy | Approved | December 20, 2024 | Priority |
| Supplement | 19 | Labeling | Approved | October 18, 2024 | 901 Required |
| Supplement | 15 | Labeling | Approved | October 18, 2024 | Standard |
| Supplement | 11 | Labeling | Approved | October 18, 2024 | Standard |
| Supplement | 6 | Efficacy | Approved | October 18, 2024 | Standard |
| Supplement | 5 | Labeling | Approved | October 18, 2024 | Standard |
| Supplement | 3 | Labeling | Approved | March 28, 2024 | Standard |
| Original application | 1 | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated | Approved | November 8, 2023 | Priority |
| Supplement | 50 | Labeling | Approved | — | Standard |
Review documents
- 0 · Supplement · September 10, 2026
- 0 · Supplement · September 10, 2026
- 0 · Supplement · September 1, 2026
- 0 · Supplement · September 1, 2026
- 0 · Supplement · September 1, 2026
- 0 · Supplement · May 11, 2026
- 0 · Supplement · March 2, 2026
- 0 · Supplement · February 27, 2026
- 0 · Supplement · January 21, 2026
- 0 · Supplement · January 21, 2026
- 0 · Supplement · January 21, 2026
- 0 · Supplement · January 21, 2026
- 0 · Supplement · January 8, 2026
- 0 · Supplement · January 8, 2026
- 0 · Supplement · January 8, 2026
- 0 · Supplement · September 26, 2025
- 0 · Supplement · September 26, 2025
- 0 · Supplement · February 10, 2025
- 0 · Supplement · February 10, 2025
- 0 · Supplement · December 26, 2024
- 0 · Supplement · December 20, 2024
- 0 · Supplement · December 20, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
- 0 · Supplement · October 21, 2024
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260828). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).
Recent Major Changes
openFDA Drug LabelingDosage and Administration ( 2.4 ) 01/2026 Warnings and Precautions Severe Gastrointestinal Adverse Reactions ( 5.2 ) 02/2026 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus ( 5.8 ) 08/2026 Suicidal Behavior and Ideation (Removed) 02/2026 Never Share a ZEPBOUND KwikPen Between Patients ( 5.10 ) 01/2026
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage. ( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. ( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4 ) 2.1 Recommended Dose Escalation Schedule The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage. Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration ( 2.2 )] . Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage. 2.2 Recommended Maintenance and Maximum Dosage Recommended Maintenance Dosage Weight Reduction and Long-Term Maintenance The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg, injected subcutaneously once weekly. OSA The recommended maintenance dosage is 10 mg or 15 mg injected subcutaneously once weekly. Maximum Recommended Dosage The maximum dosage of ZEPBOUND for all indications is 15 mg injected subcutaneously once weekly. 2.3 Recommendations Regarding Missed Dose If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours). 2.4 Important Administration Instructions Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use ] . After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following: ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection. Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen. Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity. Administer ZEPBOUND onc …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Injection: Clear, colorless to slightly yellow solution in pre-filled single-dose pens, single-dose vials, multi-dose vials, or single-patient-use KwikPens, each available in the following strengths. The multi-dose vials and single-patient-use KwikPen each contain 4 doses: Single-dose Pen or Vial 2.5 mg/0.5 mL 5 mg/0.5 mL 7.5 mg/0.5 mL 10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mL Multi-dose Vial (4 doses per vial) Dose per Injection Total Strength per Total Volume Strength per mL 2.5 mg/0.6 mL 10 mg/2.4 mL 4.17 mg/mL 5 mg/0.6 mL 20 mg/2.4 mL 8.33 mg/mL 7.5 mg/0.6 mL 30 mg/2.4 mL 12.5 mg/mL 10 mg/0.6 mL 40 mg/2.4 mL 16.7 mg/mL 12.5 mg/0.6 mL 50 mg/2.4 mL 20.8 mg/mL 15 mg/0.6 mL 60 mg/2.4 mL 25 mg/mL Single-Patient-Use KwikPen (4 doses per KwikPen) Dose per Injection Total Strength per Total Volume Strength per mL 2.5 mg 10 mg/2.4 mL 4.17 mg/mL 5 mg 20 mg/2.4 mL 8.33 mg/mL 7.5 mg 30 mg/2.4 mL 12.5 mg/mL 10 mg 40 mg/2.4 mL 16.7 mg/mL 12.5 mg 50 mg/2.4 mL 20.8 mg/mL 15 mg 60 mg/2.4 mL 25 mg/mL Injection: Single-dose pen or single-dose vial: 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, or 15 mg/0.5 mL ( 3 ) Multi-dose vial or single-patient-use KwikPen ® : 10 mg/2.4 mL (4.17 mg/mL) for four 2.5 mg/0.6 mL doses, 20 mg/2.4 mL (8.33 mg/mL) for four 5 mg/0.6 mL doses, 30 mg/2.4 mL (12.5 mg/mL) for four 7.5 mg/0.6 mL doses, 40 mg/2.4 mL (16.7 mg/mL) for four 10 mg/0.6 mL doses, 50 mg/2.4 mL (20.8 mg/mL) for four 12.5 mg/0.6 mL doses, or 60 mg/2.4 mL (25 mg/mL) for four 15 mg/0.6 mL ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS ZEPBOUND is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] . Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 ( 4 ) Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND ( 4 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. ( 5.2 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.3 ) Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.4 ) Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. ( 5.6 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.7 ) Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Monitor patients with a history of diabetic retinopathy for progression. ( 5.8 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 ) Never share a ZEPBOUND KwikPen between patients, even if the pen needle is changed. ( 5.10 ) 5.1 Risk of Thyroid C-Cell Tumors In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. 5.2 Severe Gastrointestinal Adverse Reactions Use of ZEPBOUND has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6 )] . In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving ZEPBOUND (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1%). Similar rates of severe gastrointestinal adverse reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND clinical trials for OSA. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. ZEPBOUND is not recommended in patients with severe gastroparesis. 5.3 Acute Kidney Injury Due to …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with ZEPBOUND are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients for Weight Reduction and Long-Term Maintenance Pool of Placebo - Controlled Weight Reduction Trials in Adults with Obesity or Overweight, with or without Type 2 Diabetes (Study 1 and Study 2) ZEPBOUND was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 2,519 adult patients with obesity or overweight treated with ZEPBOUND for up to 72 weeks and a 4-week off drug follow-up period (Study 1 and Study 2) [see Clinical Studies ( 14.1 )] . The mean age of patients was 47 years and 37% were male. The population was 72% White, 12% Asian, 8% Black or African American, and 7% American Indian or Alaska Native; 51% identified as Hispanic or Latino ethnicity. Baseline characteristics included an average BMI of 37.4 kg/m 2 , 29% with a BMI ≥40 kg/m 2 , 41% with hypertension, 37% with dyslipidemia, 25% with type 2 diabetes mellitus, 7% with obstructive sleep apnea, and 4% with cardiovascular (CV) disease. Across both trials, 4.8%, 6.3%, and 6.7% of patients treated with 5 mg, 10 mg, and 15 mg of ZEPBOUND, respectively, permanently discontinued treatment as a result of adverse reactions compared to 3.4% of patients treated with placebo. The majority of patients who discontinued ZEPBOUND due to adverse reactions did so during the first few months of treatment due to gastrointestinal adverse reactions. Common Adverse Reactions Table 1 shows common adverse reactions associated with the use of ZEPBOUND in the pool of two placebo-controlled trials for weight reduction (Study 1 and Study 2). These adverse reactions occurred more commonly with ZEPBOUND than with placebo and occurred in at least 2% of patients treated with ZEPBOUND. Table 1: Adverse Reactions (≥2% and Greater than Placebo) in ZEPBOUND-Treated Adults with Obesity or Overweight in Weight Reduction and Long-term Maintenance Trials (Study 1 and Study 2) a Includes diarrhea, frequent bowel movements. b Includes constipation, feces hard. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness. d Includes multiple related adverse event terms, such as injection site bruising, injection site erythema, injection site pruritus, injection site pain, injection site rash, injection site reaction. e Includes asthenia, fatigue, lethargy, malaise. f Includes blood pressure decreased, hypotension, orthostatic hypotension. Adverse Reaction …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS ZEPBOUND delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.2 ) 7.1 Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea) ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.7 )] . 7.2 Oral Medications ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected [see Use in Specific Populations ( 8.3 ) and Clinical Pharmacology ( 12.2 , 12.3 )] .
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND. ( 8.1 ) Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation. ( 8.3 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZEPBOUND (tirzepatide) during pregnancy. Pregnant patients exposed to ZEPBOUND and healthcare providers are encouraged to register by calling 1-844-524-0039 or emailing at MILEregistry@thermofisher.com. To learn more please call or visit https://pregnancyregistry.lilly.com/zepbound. Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm. Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue ZEPBOUND when a pregnancy is recognized (see Clinical Considerations) . Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. Data Animal Data In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide [0.03-, 0.07-, and 0.5-fold the maximum recommended human dose (MRHD) of 15 mg once weekly based on AUC] during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg. In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F 1 pups from F 0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females. 8.2 Lactation Risk Summary In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal administered dose (see …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. GLP-1 is a physiological regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake. Both GIP receptors and GLP-1 receptors are found in areas of the brain involved in appetite regulation. Animal studies show that tirzepatide distributes to and activates neurons in brain regions involved in regulation of appetite and food intake.
Description
openFDA Drug Labeling11 DESCRIPTION ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C 225 H 348 N 48 O 68 . Structural formula: ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming. Structural Formula
Overdosage
openFDA Drug Labeling10 OVERDOSAGE In the event of an overdosage, contact the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of tirzepatide of approximately 5 days.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 mL (8.33 mg/mL) 0002-6103-11 4 doses of 7.5 mg/0.6 mL 30 mg/2.4 mL (12.5 mg/mL) 0002-6210-11 4 doses of 10 mg/0.6 mL 40 mg/2.4 mL (16.7 mg/mL) 0002-6304-11 4 doses of 12.5 mg/0.6 mL 50 mg/2.4 mL (20.8 mg/mL) 0002-6523-11 4 doses of 15 mg/0.6 mL 60 mg/2.4 mL (25 mg/mL) 0002-6612-11 Single-Patient-Use KwikPen (with four weekly doses) Doses per KwikPen Strength 1 pack Single-Patient-Use KwikPen NDC 4 doses of 2.5 mg 10 mg/2.4 mL (4.17 mg/mL) 0002-3566-11 4 doses of 5 mg 20 mg/2.4 mL (8.33 mg/mL) 0002-3555-11 4 doses of 7.5 mg 30 mg/2.4 mL (12.5 mg/mL) 0002-3544-11 4 doses of 10 mg 40 mg/2.4 mL (16.7 mg/mL) 0002-3533-11 4 doses of 12.5 mg 50 mg/2.4 mL (20.8 mg/mL) 0002-3522-11 4 doses of 15 mg 60 mg/2.4 mL (25 mg/mL) 0002-3511-11 16.2 Storage and Handling Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen. Protect ZEPBOUND from heat and light. Store ZEPBOUND in the original carton to protect from light. ZEPBOUND Single-dose Pen and Single-dose Vial Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days. Discard single-dose pen and single-dose vial after a total of 21 days at room temperature. ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen Unopened vial or single-patient-use KwikPen: Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator. If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days. After vial or single-patient-use KwikPen has been opened: Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)]. Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.
16.1 How Supplied ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows: Single-Dose Vial and Prefilled Pen Strength 4 pack Single-dose Pen NDC 1 pack Single-dose Vial NDC 4 pack Single-dose Vial NDC 2.5 mg/0.5 mL 0002-2506-80 0002-0152-01 0002-0152-04 5 mg/0.5 mL 0002-2495-80 0002-0243-01 0002-0243-04 7.5 mg/0.5 mL 0002-2484-80 0002-1214-01 0002-1214-04 10 mg/0.5 mL 0002-2471-80 0002-1340-01 0002-1340-04 12.5 mg/0.5 mL 0002-2460-80 0002-1423-01 0002-1423-04 15 mg/0.5 mL 0002-2457-80 0002-2002-01 0002-2002-04 Multi-Dose Vial Doses per Vial Strength 1 pack Multi-Dose Vial NDC 4 doses of 2.5 mg/0.6 mL 10 mg/2.4 mL (4.17 mg/mL) 0002-6052-11 4 doses of 5 mg/0.6 mL 20 mg/2.4 …
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TIRZEPATIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 0002-0152-01 | 0002-0152 | Eli Lilly and Company | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE | March 28, 2024 |
| 0002-0152-04 | 0002-0152 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-04) / .5 mL in 1 VIAL, SINGLE-DOSE | August 8, 2024 |
| 0002-0152-61 | 0002-0152 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-61) / .5 mL in 1 VIAL, SINGLE-DOSE | May 1, 2025 |
| 0002-0243-01 | 0002-0243 | Eli Lilly and Company | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0243-01) / .5 mL in 1 VIAL, SINGLE-DOSE | March 28, 2024 |
| 0002-0243-04 | 0002-0243 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0243-04) / .5 mL in 1 VIAL, SINGLE-DOSE | August 8, 2024 |
| 0002-1214-01 | 0002-1214 | Eli Lilly and Company | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1214-01) / .5 mL in 1 VIAL, SINGLE-DOSE | March 28, 2024 |
| 0002-1214-04 | 0002-1214 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-1214-04) / .5 mL in 1 VIAL, SINGLE-DOSE | February 18, 2025 |
| 0002-1340-01 | 0002-1340 | Eli Lilly and Company | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1340-01) / .5 mL in 1 VIAL, SINGLE-DOSE | March 28, 2024 |
| 0002-1340-04 | 0002-1340 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-1340-04) / .5 mL in 1 VIAL, SINGLE-DOSE | February 18, 2025 |
| 0002-1423-01 | 0002-1423 | Eli Lilly and Company | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1423-01) / .5 mL in 1 VIAL, SINGLE-DOSE | March 28, 2024 |
| 0002-1423-04 | 0002-1423 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-1423-04) / .5 mL in 1 VIAL, SINGLE-DOSE | July 7, 2025 |
| 0002-2002-01 | 0002-2002 | Eli Lilly and Company | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-2002-01) / .5 mL in 1 VIAL, SINGLE-DOSE | March 28, 2024 |
| 0002-2002-04 | 0002-2002 | Eli Lilly and Company | 4 VIAL, SINGLE-DOSE in 1 CARTON (0002-2002-04) / .5 mL in 1 VIAL, SINGLE-DOSE | July 7, 2025 |
| 0002-2457-80 | 0002-2457 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2457-80) / .5 mL in 1 SYRINGE (0002-2457-01) | November 8, 2023 |
| 0002-2460-80 | 0002-2460 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2460-80) / .5 mL in 1 SYRINGE (0002-2460-01) | November 8, 2023 |
| 0002-2471-80 | 0002-2471 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2471-80) / .5 mL in 1 SYRINGE (0002-2471-01) | November 8, 2023 |
| 0002-2484-80 | 0002-2484 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2484-80) / .5 mL in 1 SYRINGE (0002-2484-01) | November 8, 2023 |
| 0002-2495-80 | 0002-2495 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2495-80) / .5 mL in 1 SYRINGE (0002-2495-01) | November 8, 2023 |
| 0002-2506-61 | 0002-2506 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2506-61) / .5 mL in 1 SYRINGE | November 8, 2023 |
| 0002-2506-80 | 0002-2506 | Eli Lilly and Company | 4 SYRINGE in 1 CARTON (0002-2506-80) / .5 mL in 1 SYRINGE (0002-2506-01) | November 8, 2023 |
| 0002-3511-11 | 0002-3511 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3511-11) / 2.4 mL in 1 SYRINGE (0002-3511-01) | January 20, 2026 |
| 0002-3522-11 | 0002-3522 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3522-11) / 2.4 mL in 1 SYRINGE (0002-3522-01) | January 20, 2026 |
| 0002-3533-11 | 0002-3533 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3533-11) / 2.4 mL in 1 SYRINGE (0002-3533-01) | January 20, 2026 |
| 0002-3544-11 | 0002-3544 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3544-11) / 2.4 mL in 1 SYRINGE (0002-3544-01) | January 20, 2026 |
| 0002-3555-11 | 0002-3555 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3555-11) / 2.4 mL in 1 SYRINGE (0002-3555-01) | January 20, 2026 |
| 0002-3566-11 | 0002-3566 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3566-11) / 2.4 mL in 1 SYRINGE (0002-3566-01) | January 20, 2026 |
| 0002-3566-99 | 0002-3566 | Eli Lilly and Company | 1 SYRINGE in 1 CARTON (0002-3566-99) / 2.4 mL in 1 SYRINGE | March 1, 2026 |
| 0002-6052-11 | 0002-6052 | Eli Lilly and Company | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6052-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6052-01) | January 7, 2026 |
| 0002-6103-11 | 0002-6103 | Eli Lilly and Company | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6103-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6103-01) | January 7, 2026 |
| 0002-6210-11 | 0002-6210 | Eli Lilly and Company | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6210-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6210-01) | January 7, 2026 |
| 0002-6304-11 | 0002-6304 | Eli Lilly and Company | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6304-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6304-01) | January 7, 2026 |
| 0002-6523-11 | 0002-6523 | Eli Lilly and Company | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6523-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6523-01) | January 7, 2026 |
| 0002-6612-11 | 0002-6612 | Eli Lilly and Company | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-6612-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6612-01) | January 7, 2026 |
| 0002-0152 | 0002-0152 | Eli Lilly and Company | — | March 28, 2024 |
| 0002-0243 | 0002-0243 | Eli Lilly and Company | — | March 28, 2024 |
| 0002-1214 | 0002-1214 | Eli Lilly and Company | — | March 28, 2024 |
| 0002-1340 | 0002-1340 | Eli Lilly and Company | — | March 28, 2024 |
| 0002-1423 | 0002-1423 | Eli Lilly and Company | — | March 28, 2024 |
| 0002-2002 | 0002-2002 | Eli Lilly and Company | — | March 28, 2024 |
| 0002-2457 | 0002-2457 | Eli Lilly and Company | — | November 8, 2023 |
| 0002-2460 | 0002-2460 | Eli Lilly and Company | — | November 8, 2023 |
| 0002-2471 | 0002-2471 | Eli Lilly and Company | — | November 8, 2023 |
| 0002-2484 | 0002-2484 | Eli Lilly and Company | — | November 8, 2023 |
| 0002-2495 | 0002-2495 | Eli Lilly and Company | — | November 8, 2023 |
| 0002-2506 | 0002-2506 | Eli Lilly and Company | — | November 8, 2023 |
| 0002-3511 | 0002-3511 | Eli Lilly and Company | — | January 20, 2026 |
| 0002-3522 | 0002-3522 | Eli Lilly and Company | — | January 20, 2026 |
| 0002-3533 | 0002-3533 | Eli Lilly and Company | — | January 20, 2026 |
| 0002-3544 | 0002-3544 | Eli Lilly and Company | — | January 20, 2026 |
| 0002-3555 | 0002-3555 | Eli Lilly and Company | — | January 20, 2026 |
| 0002-3566 | 0002-3566 | Eli Lilly and Company | — | January 20, 2026 |
| 0002-6052 | 0002-6052 | Eli Lilly and Company | — | January 7, 2026 |
| 0002-6103 | 0002-6103 | Eli Lilly and Company | — | January 7, 2026 |
| 0002-6210 | 0002-6210 | Eli Lilly and Company | — | January 7, 2026 |
| 0002-6304 | 0002-6304 | Eli Lilly and Company | — | January 7, 2026 |
| 0002-6523 | 0002-6523 | Eli Lilly and Company | — | January 7, 2026 |
| 0002-6612 | 0002-6612 | Eli Lilly and Company | — | January 7, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.