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UZEDY

risperidone · Injection, Suspension, 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
UZEDY
Generic name
risperidone
Dosage form
Injection, Suspension, Extended Release
Route
Subcutaneous
Marketing category
NDA · NDA
Labeler
Teva Pharmaceuticals USA, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
7
NDC product codes
7
Packages
14
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Risperidone 100 mg/.28mL 312832 View
Risperidone 125 mg/.35mL 312832 View
Risperidone 150 mg/.42mL 312832 View
Risperidone 200 mg/.56mL 312832 View
Risperidone 250 mg/.7mL 312832 View
Risperidone 50 mg/.14mL 312832 View
Risperidone 75 mg/.21mL 312832 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Suspension, Extended Release
Route of administration
Subcutaneous
Presentations
21

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Atypical Antipsychotic [EPC] EPC All 62 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
213586
Application type
NDA · New Drug Application
Approval date
April 28, 2023
Sponsor
TEVA
Products on application
7
Submissions recorded
5
Products approved under application 213586.
Product Trade name Form Strength Ingredient Status TE Flags
213586-001 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS
213586-002 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS
213586-003 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS
213586-004 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS
213586-005 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS
213586-006 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS
213586-007 UZEDY SUSPENSION, EXTENDED RELEASE RISPERIDONE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE 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 listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8221778 November 12, 2027 001 No U-601 May 3, 2023
8221778 November 12, 2027 001 No U-543 May 3, 2023
8741327 November 12, 2027 001 No U-543 May 3, 2023
8221778 November 12, 2027 002 No U-601 May 3, 2023
8221778 November 12, 2027 002 No U-543 May 3, 2023
8741327 November 12, 2027 002 No U-543 May 3, 2023
8221778 November 12, 2027 003 No U-601 May 3, 2023
8221778 November 12, 2027 003 No U-543 May 3, 2023
8741327 November 12, 2027 003 No U-543 May 3, 2023
8221778 November 12, 2027 004 No U-543 May 3, 2023
8741327 November 12, 2027 004 No U-543 May 3, 2023
8221778 November 12, 2027 005 No U-543 May 3, 2023
8741327 November 12, 2027 005 No U-543 May 3, 2023
8221778 November 12, 2027 006 No U-543 May 3, 2023
8741327 November 12, 2027 006 No U-543 May 3, 2023
8221778 November 12, 2027 007 No U-543 May 3, 2023
8741327 November 12, 2027 007 No U-543 May 3, 2023
9023897 April 5, 2033 001 No May 3, 2023
9023897 April 5, 2033 002 No May 3, 2023
9023897 April 5, 2033 003 No May 3, 2023
9023897 April 5, 2033 004 No May 3, 2023
9023897 April 5, 2033 005 No May 3, 2023
9023897 April 5, 2033 006 No May 3, 2023
9023897 April 5, 2033 007 No May 3, 2023
12128132 September 11, 2040 001 No U-601 November 18, 2024
12383493 September 11, 2040 001 No U-601 September 8, 2025
12383493 September 11, 2040 001 No U-543 September 8, 2025
12128132 September 11, 2040 001 No U-543 November 18, 2024
12128132 September 11, 2040 002 No U-601 November 18, 2024
12383493 September 11, 2040 002 No U-601 September 8, 2025
12383493 September 11, 2040 002 No U-543 September 8, 2025
12128132 September 11, 2040 002 No U-543 November 18, 2024
12128132 September 11, 2040 003 No U-601 November 18, 2024
12383493 September 11, 2040 003 No U-601 September 8, 2025
12383493 September 11, 2040 003 No U-543 September 8, 2025
12128132 September 11, 2040 003 No U-543 November 18, 2024
12383493 September 11, 2040 004 No U-543 September 8, 2025
12128132 September 11, 2040 004 No U-543 November 18, 2024
12383493 September 11, 2040 005 No U-543 September 8, 2025
12128132 September 11, 2040 005 No U-543 November 18, 2024
12383493 September 11, 2040 006 No U-543 September 8, 2025
12128132 September 11, 2040 006 No U-543 November 18, 2024
12383493 September 11, 2040 007 No U-543 September 8, 2025
12128132 September 11, 2040 007 No U-543 November 18, 2024
12329851 March 17, 2042 001 No U-4214 July 14, 2025
12329851 March 17, 2042 002 No U-4214 July 14, 2025
12329851 March 17, 2042 003 No U-4214 July 14, 2025
12329851 March 17, 2042 004 No U-4214 July 14, 2025
12329851 March 17, 2042 005 No U-4214 July 14, 2025
12329851 March 17, 2042 006 No U-4214 July 14, 2025
12329851 March 17, 2042 007 No U-4214 July 14, 2025
Regulatory exclusivity periods.
Code Expires Product
NP April 28, 2026 001
NP April 28, 2026 002
NP April 28, 2026 003
NP April 28, 2026 004
NP April 28, 2026 005
NP April 28, 2026 006
NP April 28, 2026 007

Approval history

Source: Drugs@FDA
Most recent submissions on application 213586.
Type No. Action Status Date Review
Supplement 9 Labeling Approved October 10, 2025 Standard
Supplement 8 Efficacy Approved October 10, 2025 Standard
Supplement 7 Labeling Approved January 22, 2025 Standard
Supplement 1 Labeling Approved November 1, 2023 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved April 28, 2023 Standard

Review documents

  • 0 · Supplement · October 15, 2025
  • 0 · Supplement · October 15, 2025
  • 0 · Supplement · October 14, 2025
  • 0 · Supplement · October 14, 2025
  • 0 · Supplement · February 7, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Original application · March 6, 2024
  • 0 · Supplement · November 2, 2023
  • 0 · Original application · May 1, 2023
  • 0 · Original application · May 1, 2023

Adverse event reports

Source: openFDA FAERS
131,094
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
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: RISPERIDONE. 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
51759-305-10 51759-305 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS May 1, 2023
51759-305-11 51759-305 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-305-11) / .14 mL in 1 SYRINGE, GLASS May 1, 2023
51759-410-10 51759-410 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-410-10) / .21 mL in 1 SYRINGE, GLASS May 1, 2023
51759-410-11 51759-410 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-410-11) / .21 mL in 1 SYRINGE, GLASS May 1, 2023
51759-520-10 51759-520 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-520-10) / .28 mL in 1 SYRINGE, GLASS May 1, 2023
51759-520-11 51759-520 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-520-11) / .28 mL in 1 SYRINGE, GLASS May 1, 2023
51759-630-10 51759-630 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-630-10) / .35 mL in 1 SYRINGE, GLASS May 1, 2023
51759-630-11 51759-630 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-630-11) / .35 mL in 1 SYRINGE, GLASS May 1, 2023
51759-740-10 51759-740 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-740-10) / .42 mL in 1 SYRINGE, GLASS May 1, 2023
51759-740-11 51759-740 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-740-11) / .42 mL in 1 SYRINGE, GLASS May 1, 2023
51759-850-10 51759-850 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-850-10) / .56 mL in 1 SYRINGE, GLASS May 1, 2023
51759-850-11 51759-850 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-850-11) / .56 mL in 1 SYRINGE, GLASS May 1, 2023
51759-960-10 51759-960 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-960-10) / .7 mL in 1 SYRINGE, GLASS May 1, 2023
51759-960-11 51759-960 Teva Pharmaceuticals USA, Inc. 1 SYRINGE, GLASS in 1 CARTON (51759-960-11) / .7 mL in 1 SYRINGE, GLASS May 1, 2023
51759-305 51759-305 Teva Pharmaceuticals USA, Inc. — May 1, 2023
51759-410 51759-410 Teva Pharmaceuticals USA, Inc. — May 1, 2023
51759-520 51759-520 Teva Pharmaceuticals USA, Inc. — May 1, 2023
51759-630 51759-630 Teva Pharmaceuticals USA, Inc. — May 1, 2023
51759-740 51759-740 Teva Pharmaceuticals USA, Inc. — May 1, 2023
51759-850 51759-850 Teva Pharmaceuticals USA, Inc. — May 1, 2023
51759-960 51759-960 Teva Pharmaceuticals USA, Inc. — May 1, 2023

Sources for this page

Every dataset that contributed a fact to 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 · 11 sections on this page.