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AUSTEDO XR
deutetrabenazine · Tablet, Film Coated, Extended Release
Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
AUSTEDO XR
Generic name
deutetrabenazine
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Teva Neuroscience, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
8
NDC product codes
8
Packages
8
Data completeness
60%
of corroborating sources present
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Deutetrabenazine | 12 mg/1 | 1876910 | View |
| Deutetrabenazine | 18 mg/1 | 1876910 | View |
| Deutetrabenazine | 24 mg/1 | 1876910 | View |
| Deutetrabenazine | 30 mg/1 | 1876910 | View |
| Deutetrabenazine | 36 mg/1 | 1876910 | View |
| Deutetrabenazine | 42 mg/1 | 1876910 | View |
| Deutetrabenazine | 48 mg/1 | 1876910 | View |
| Deutetrabenazine | 6 mg/1 | 1876910 | View |
Forms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
16
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
216354
Application type
NDA · New Drug Application
Approval date
February 17, 2023
Sponsor
TEVA
Products on application
8
Submissions recorded
4
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 216354-001 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD | |
| 216354-002 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD | |
| 216354-003 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD | |
| 216354-004 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD | |
| 216354-005 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD | |
| 216354-006 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD | |
| 216354-007 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD RS | |
| 216354-008 | AUSTEDO XR | TABLET, EXTENDED RELEASE | DEUTETRABENAZINE | Prescription | — | RLD |
Therapeutic equivalence
Source: Orange BookTE code
—
Reference Listed Drug
Yes
Reference Standard
Yes
Codes 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 |
|---|---|---|---|---|---|
| 8524733 | April 3, 2031 | 001 | Yes | February 27, 2023 | |
| 8524733 | April 3, 2031 | 002 | Yes | February 27, 2023 | |
| 8524733 | April 3, 2031 | 003 | Yes | February 27, 2023 | |
| 8524733 | April 3, 2031 | 004 | Yes | July 25, 2024 | |
| 8524733 | April 3, 2031 | 005 | Yes | July 25, 2024 | |
| 8524733 | April 3, 2031 | 006 | Yes | July 25, 2024 | |
| 8524733 | April 3, 2031 | 007 | Yes | July 25, 2024 | |
| 8524733 | April 3, 2031 | 008 | Yes | July 25, 2024 | |
| 8524733*PED | October 3, 2031 | 001 | No | — | |
| 8524733*PED | October 3, 2031 | 002 | No | — | |
| 8524733*PED | October 3, 2031 | 003 | No | — | |
| 8524733*PED | October 3, 2031 | 004 | No | — | |
| 8524733*PED | October 3, 2031 | 005 | No | — | |
| 8524733*PED | October 3, 2031 | 006 | No | — | |
| 8524733*PED | October 3, 2031 | 007 | No | — | |
| 8524733*PED | October 3, 2031 | 008 | No | — | |
| 9550780 | September 18, 2033 | 001 | Yes | U-1995 | February 27, 2023 |
| 9550780 | September 18, 2033 | 001 | Yes | U-3055 | February 27, 2023 |
| 9550780 | September 18, 2033 | 002 | Yes | U-3055 | February 27, 2023 |
| 9550780 | September 18, 2033 | 002 | Yes | U-1995 | February 27, 2023 |
| 9550780 | September 18, 2033 | 003 | Yes | U-3055 | February 27, 2023 |
| 9550780 | September 18, 2033 | 003 | Yes | U-1995 | February 27, 2023 |
| 9550780 | September 18, 2033 | 004 | Yes | U-1995 | July 25, 2024 |
| 9550780 | September 18, 2033 | 004 | Yes | U-3055 | July 25, 2024 |
| 9550780 | September 18, 2033 | 005 | Yes | U-3055 | July 25, 2024 |
| 9550780 | September 18, 2033 | 005 | Yes | U-1995 | July 25, 2024 |
| 9550780 | September 18, 2033 | 006 | Yes | U-3055 | July 25, 2024 |
| 9550780 | September 18, 2033 | 006 | Yes | U-1995 | July 25, 2024 |
| 9550780 | September 18, 2033 | 007 | Yes | U-3055 | July 25, 2024 |
| 9550780 | September 18, 2033 | 007 | Yes | U-1995 | July 25, 2024 |
| 9550780 | September 18, 2033 | 008 | Yes | U-3055 | July 25, 2024 |
| 9550780 | September 18, 2033 | 008 | Yes | U-1995 | July 25, 2024 |
| 9550780*PED | March 18, 2034 | 001 | No | — | |
| 9550780*PED | March 18, 2034 | 002 | No | — | |
| 9550780*PED | March 18, 2034 | 003 | No | — | |
| 9550780*PED | March 18, 2034 | 004 | No | — | |
| 9550780*PED | March 18, 2034 | 005 | No | — | |
| 9550780*PED | March 18, 2034 | 006 | No | — | |
| 9550780*PED | March 18, 2034 | 007 | No | — | |
| 9550780*PED | March 18, 2034 | 008 | No | — | |
| 12016858 | March 7, 2036 | 001 | No | U-1995 | July 25, 2024 |
| 12016858 | March 7, 2036 | 001 | No | U-3055 | July 25, 2024 |
| 10959996 | March 7, 2036 | 001 | No | U-3055 | February 27, 2023 |
| 11564917 | March 7, 2036 | 001 | No | U-1995 | February 27, 2023 |
| 11446291 | March 7, 2036 | 001 | No | U-1995 | February 27, 2023 |
| 11357772 | March 7, 2036 | 001 | No | U-1995 | February 27, 2023 |
| 11357772 | March 7, 2036 | 001 | No | U-3055 | February 27, 2023 |
| 11648244 | March 7, 2036 | 001 | No | U-1995 | June 5, 2023 |
| 12016858 | March 7, 2036 | 002 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 002 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 002 | No | U-3055 | February 27, 2023 |
| 11564917 | March 7, 2036 | 002 | No | U-1995 | February 27, 2023 |
| 11446291 | March 7, 2036 | 002 | No | U-1995 | February 27, 2023 |
| 11357772 | March 7, 2036 | 002 | No | U-3055 | February 27, 2023 |
| 11357772 | March 7, 2036 | 002 | No | U-1995 | February 27, 2023 |
| 11648244 | March 7, 2036 | 002 | No | U-1995 | June 5, 2023 |
| 12016858 | March 7, 2036 | 003 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 003 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 003 | No | U-3055 | February 27, 2023 |
| 11564917 | March 7, 2036 | 003 | No | U-1995 | February 27, 2023 |
| 11446291 | March 7, 2036 | 003 | No | U-1995 | February 27, 2023 |
| 11357772 | March 7, 2036 | 003 | No | U-3055 | February 27, 2023 |
| 11357772 | March 7, 2036 | 003 | No | U-1995 | February 27, 2023 |
| 11648244 | March 7, 2036 | 003 | No | U-1995 | June 5, 2023 |
| 11446291 | March 7, 2036 | 004 | No | U-1995 | July 25, 2024 |
| 11564917 | March 7, 2036 | 004 | No | U-1995 | July 25, 2024 |
| 11648244 | March 7, 2036 | 004 | No | U-1995 | July 25, 2024 |
| 12016858 | March 7, 2036 | 004 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 004 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 004 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 004 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 004 | No | U-1995 | July 25, 2024 |
| 11446291 | March 7, 2036 | 005 | No | U-1995 | July 25, 2024 |
| 11564917 | March 7, 2036 | 005 | No | U-1995 | July 25, 2024 |
| 11648244 | March 7, 2036 | 005 | No | U-1995 | July 25, 2024 |
| 12016858 | March 7, 2036 | 005 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 005 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 005 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 005 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 005 | No | U-1995 | July 25, 2024 |
| 11446291 | March 7, 2036 | 006 | No | U-1995 | July 25, 2024 |
| 11564917 | March 7, 2036 | 006 | No | U-1995 | July 25, 2024 |
| 11648244 | March 7, 2036 | 006 | No | U-1995 | July 25, 2024 |
| 12016858 | March 7, 2036 | 006 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 006 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 006 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 006 | No | U-1995 | July 25, 2024 |
| 11357772 | March 7, 2036 | 006 | No | U-3055 | July 25, 2024 |
| 11446291 | March 7, 2036 | 007 | No | U-1995 | July 25, 2024 |
| 11564917 | March 7, 2036 | 007 | No | U-1995 | July 25, 2024 |
| 11648244 | March 7, 2036 | 007 | No | U-1995 | July 25, 2024 |
| 12016858 | March 7, 2036 | 007 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 007 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 007 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 007 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 007 | No | U-1995 | July 25, 2024 |
| 11446291 | March 7, 2036 | 008 | No | U-1995 | July 25, 2024 |
| 11564917 | March 7, 2036 | 008 | No | U-1995 | July 25, 2024 |
| 11648244 | March 7, 2036 | 008 | No | U-1995 | July 25, 2024 |
| 12016858 | March 7, 2036 | 008 | No | U-3055 | July 25, 2024 |
| 12016858 | March 7, 2036 | 008 | No | U-1995 | July 25, 2024 |
| 10959996 | March 7, 2036 | 008 | No | U-3055 | July 25, 2024 |
| 11357772 | March 7, 2036 | 008 | No | U-1995 | July 25, 2024 |
| 11357772 | March 7, 2036 | 008 | No | U-3055 | July 25, 2024 |
| 11648244*PED | September 7, 2036 | 001 | No | — | |
| 12016858*PED | September 7, 2036 | 001 | No | — | |
| 10959996*PED | September 7, 2036 | 001 | No | — | |
| 11564917*PED | September 7, 2036 | 001 | No | — | |
| 11446291*PED | September 7, 2036 | 001 | No | — | |
| 11357772*PED | September 7, 2036 | 001 | No | — | |
| 11648244*PED | September 7, 2036 | 002 | No | — | |
| 12016858*PED | September 7, 2036 | 002 | No | — | |
| 10959996*PED | September 7, 2036 | 002 | No | — | |
| 11564917*PED | September 7, 2036 | 002 | No | — | |
| 11446291*PED | September 7, 2036 | 002 | No | — | |
| 11357772*PED | September 7, 2036 | 002 | No | — | |
| 11648244*PED | September 7, 2036 | 003 | No | — | |
| 12016858*PED | September 7, 2036 | 003 | No | — | |
| 10959996*PED | September 7, 2036 | 003 | No | — | |
| 11564917*PED | September 7, 2036 | 003 | No | — | |
| 11446291*PED | September 7, 2036 | 003 | No | — | |
| 11357772*PED | September 7, 2036 | 003 | No | — | |
| 11446291*PED | September 7, 2036 | 004 | No | — | |
| 11564917*PED | September 7, 2036 | 004 | No | — | |
| 11648244*PED | September 7, 2036 | 004 | No | — | |
| 10959996*PED | September 7, 2036 | 004 | No | — | |
| 11357772*PED | September 7, 2036 | 004 | No | — | |
| 12016858*PED | September 7, 2036 | 004 | No | — | |
| 11446291*PED | September 7, 2036 | 005 | No | — | |
| 11564917*PED | September 7, 2036 | 005 | No | — | |
| 11648244*PED | September 7, 2036 | 005 | No | — | |
| 10959996*PED | September 7, 2036 | 005 | No | — | |
| 11357772*PED | September 7, 2036 | 005 | No | — | |
| 12016858*PED | September 7, 2036 | 005 | No | — | |
| 11446291*PED | September 7, 2036 | 006 | No | — | |
| 11564917*PED | September 7, 2036 | 006 | No | — | |
| 11648244*PED | September 7, 2036 | 006 | No | — | |
| 10959996*PED | September 7, 2036 | 006 | No | — | |
| 11357772*PED | September 7, 2036 | 006 | No | — | |
| 12016858*PED | September 7, 2036 | 006 | No | — | |
| 11446291*PED | September 7, 2036 | 007 | No | — | |
| 11564917*PED | September 7, 2036 | 007 | No | — | |
| 11648244*PED | September 7, 2036 | 007 | No | — | |
| 10959996*PED | September 7, 2036 | 007 | No | — | |
| 11357772*PED | September 7, 2036 | 007 | No | — | |
| 12016858*PED | September 7, 2036 | 007 | No | — | |
| 11446291*PED | September 7, 2036 | 008 | No | — | |
| 11564917*PED | September 7, 2036 | 008 | No | — | |
| 11648244*PED | September 7, 2036 | 008 | No | — | |
| 10959996*PED | September 7, 2036 | 008 | No | — | |
| 11357772*PED | September 7, 2036 | 008 | No | — | |
| 12016858*PED | September 7, 2036 | 008 | No | — | |
| 11179386 | March 15, 2038 | 001 | No | U-1995 | February 27, 2023 |
| 11179386 | March 15, 2038 | 001 | No | U-3055 | February 27, 2023 |
| 11813232 | March 15, 2038 | 001 | No | December 7, 2023 | |
| 11179386 | March 15, 2038 | 002 | No | U-3055 | February 27, 2023 |
| 11179386 | March 15, 2038 | 002 | No | U-1995 | February 27, 2023 |
| 11813232 | March 15, 2038 | 002 | No | December 7, 2023 | |
| 11179386 | March 15, 2038 | 003 | No | U-3055 | February 27, 2023 |
| 11179386 | March 15, 2038 | 003 | No | U-1995 | February 27, 2023 |
| 11813232 | March 15, 2038 | 003 | No | December 7, 2023 | |
| 11179386 | March 15, 2038 | 004 | No | U-1995 | July 25, 2024 |
| 11179386 | March 15, 2038 | 004 | No | U-3055 | July 25, 2024 |
| 11813232 | March 15, 2038 | 004 | No | July 25, 2024 | |
| 11179386 | March 15, 2038 | 005 | No | U-3055 | July 25, 2024 |
| 11179386 | March 15, 2038 | 005 | No | U-1995 | July 25, 2024 |
| 11813232 | March 15, 2038 | 005 | No | July 25, 2024 | |
| 11179386 | March 15, 2038 | 006 | No | U-3055 | July 25, 2024 |
| 11179386 | March 15, 2038 | 006 | No | U-1995 | July 25, 2024 |
| 11813232 | March 15, 2038 | 006 | No | July 25, 2024 | |
| 11179386 | March 15, 2038 | 007 | No | U-1995 | July 25, 2024 |
| 11179386 | March 15, 2038 | 007 | No | U-3055 | July 25, 2024 |
| 11813232 | March 15, 2038 | 007 | No | July 25, 2024 | |
| 11179386 | March 15, 2038 | 008 | No | U-3055 | July 25, 2024 |
| 11179386 | March 15, 2038 | 008 | No | U-1995 | July 25, 2024 |
| 11813232 | March 15, 2038 | 008 | No | July 25, 2024 | |
| 11813232*PED | September 15, 2038 | 001 | No | — | |
| 11179386*PED | September 15, 2038 | 001 | No | — | |
| 11813232*PED | September 15, 2038 | 002 | No | — | |
| 11179386*PED | September 15, 2038 | 002 | No | — | |
| 11813232*PED | September 15, 2038 | 003 | No | — | |
| 11179386*PED | September 15, 2038 | 003 | No | — | |
| 11813232*PED | September 15, 2038 | 004 | No | — | |
| 11179386*PED | September 15, 2038 | 004 | No | — | |
| 11813232*PED | September 15, 2038 | 005 | No | — | |
| 11179386*PED | September 15, 2038 | 005 | No | — | |
| 11813232*PED | September 15, 2038 | 006 | No | — | |
| 11179386*PED | September 15, 2038 | 006 | No | — | |
| 11813232*PED | September 15, 2038 | 007 | No | — | |
| 11179386*PED | September 15, 2038 | 007 | No | — | |
| 11813232*PED | September 15, 2038 | 008 | No | — | |
| 11179386*PED | September 15, 2038 | 008 | No | — | |
| 11311488 | June 10, 2041 | 001 | No | U-1995 | February 27, 2023 |
| 11311488 | June 10, 2041 | 001 | No | U-3055 | February 27, 2023 |
| 12599598 | June 10, 2041 | 001 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 001 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 001 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 001 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 002 | No | U-3055 | February 27, 2023 |
| 11311488 | June 10, 2041 | 002 | No | U-1995 | February 27, 2023 |
| 12599598 | June 10, 2041 | 002 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 002 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 002 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 002 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 003 | No | U-3055 | February 27, 2023 |
| 11311488 | June 10, 2041 | 003 | No | U-1995 | February 27, 2023 |
| 12599598 | June 10, 2041 | 003 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 003 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 003 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 003 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 004 | No | U-1995 | July 25, 2024 |
| 11311488 | June 10, 2041 | 004 | No | U-3055 | July 25, 2024 |
| 12599598 | June 10, 2041 | 004 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 004 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 004 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 004 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 005 | No | U-3055 | July 25, 2024 |
| 11311488 | June 10, 2041 | 005 | No | U-1995 | July 25, 2024 |
| 12599598 | June 10, 2041 | 005 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 005 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 005 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 005 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 006 | No | U-3055 | July 25, 2024 |
| 11311488 | June 10, 2041 | 006 | No | U-1995 | July 25, 2024 |
| 12599598 | June 10, 2041 | 006 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 006 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 006 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 006 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 007 | No | U-3055 | July 25, 2024 |
| 11311488 | June 10, 2041 | 007 | No | U-1995 | July 25, 2024 |
| 12599598 | June 10, 2041 | 007 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 007 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 007 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 007 | No | U-1995 | April 29, 2026 |
| 11311488 | June 10, 2041 | 008 | No | U-3055 | July 25, 2024 |
| 11311488 | June 10, 2041 | 008 | No | U-1995 | July 25, 2024 |
| 12599598 | June 10, 2041 | 008 | No | U-3055 | April 29, 2026 |
| 12599598 | June 10, 2041 | 008 | No | U-1995 | April 29, 2026 |
| 12589075 | June 10, 2041 | 008 | No | U-3055 | April 29, 2026 |
| 12589075 | June 10, 2041 | 008 | No | U-1995 | April 29, 2026 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 8 | Labeling | Approved | February 28, 2025 | Standard |
| Supplement | 7 | Manufacturing (CMC) | Approved | July 1, 2024 | N/A |
| Supplement | 6 | Manufacturing (CMC) | Approved | May 29, 2024 | N/A |
| Original application | 1 | Type 3 - New Dosage Form | Approved | February 17, 2023 | Standard |
Review documents
- 0 · Supplement · June 2, 2025
- 0 · Supplement · March 3, 2025
- 0 · Supplement · March 3, 2025
- 0 · Supplement · July 8, 2024
- 0 · Supplement · July 2, 2024
- 0 · Supplement · May 31, 2024
- 0 · Supplement · May 30, 2024
- 0 · Original application · January 26, 2024
- 0 · Original application · February 21, 2023
- 0 · Original application · February 17, 2023
Adverse event reports
Source: openFDA FAERS7,234
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: DEUTETRABENAZINE. 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 |
|---|---|---|---|---|
| 68546-470-56 | 68546-470 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-470-56) | February 21, 2023 |
| 68546-471-56 | 68546-471 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-471-56) | February 21, 2023 |
| 68546-472-56 | 68546-472 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-472-56) | February 21, 2023 |
| 68546-473-56 | 68546-473 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-473-56) | May 29, 2024 |
| 68546-474-56 | 68546-474 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-474-56) | May 29, 2024 |
| 68546-475-56 | 68546-475 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-475-56) | May 29, 2024 |
| 68546-476-56 | 68546-476 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-476-56) | May 29, 2024 |
| 68546-479-56 | 68546-479 | Teva Neuroscience, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-479-56) | July 1, 2024 |
| 68546-470 | 68546-470 | Teva Neuroscience, Inc. | — | February 21, 2023 |
| 68546-471 | 68546-471 | Teva Neuroscience, Inc. | — | February 21, 2023 |
| 68546-472 | 68546-472 | Teva Neuroscience, Inc. | — | February 21, 2023 |
| 68546-473 | 68546-473 | Teva Neuroscience, Inc. | — | May 29, 2024 |
| 68546-474 | 68546-474 | Teva Neuroscience, Inc. | — | May 29, 2024 |
| 68546-475 | 68546-475 | Teva Neuroscience, Inc. | — | May 29, 2024 |
| 68546-476 | 68546-476 | Teva Neuroscience, Inc. | — | May 29, 2024 |
| 68546-479 | 68546-479 | Teva Neuroscience, Inc. | — | July 1, 2024 |
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 |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.