NDC 12496-0776-2 - PERSERIS
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 12496-0776
- Requested NDC
- 12496-0776-2
- Package NDCs from labels
- 12496-0776-5, 12496-0776-2
- Manufacturer
- Indivior Inc. | Curia Massachusetts, Inc. | Curia Global, Inc. | Assia Chemical Industries Ltd (Teva Tech site) | Eurofins Lancaster Laboratories, Inc | Isomedix Operations Inc | Nelson Laboratories, LLC | Patheon Manufacturing Services LLC | SGS North America Inc | Sharp Packaging Services, LLC | Spectral Data Services, Inc. | SYNERGY HEALTH AST, LLC | Teva API India Private Ltd.
- Effective date
- 2025-01-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PERSERIS | Indivior Inc. | Curia Massachusetts, Inc. | Curia Global, Inc. | Assia Chemical Industries Ltd (Teva Tech site) | Eurofins Lancaster Laboratories, Inc | Isomedix Operations Inc | Nelson Laboratories, LLC | Patheon Manufacturing Services LLC | SGS North America Inc | Sharp Packaging Services, LLC | Spectral Data Services, Inc. | SYNERGY HEALTH AST, LLC | Teva API India Private Ltd. | 2025-01-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 12496-0776 | PERSERIS (RISPERIDONE) KIT [INDIVIOR INC.] | 18 | Unmatched | 20250221_a4f21b1a-5691-4b14-a56d-651962d06f39.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Risperidone | RISPERIDONE | APOZEAL PHARMACEUTICALS INC | 4ab6d256-6590-45be-a5df-f505987f96c3 | 2026-08-30 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 701e1cd8-2868-4d29-85a9-a2212c88165f | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Amerisyn LLC | 58b7504f-c4a3-ef1b-e063-6394a90ac0f3 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 5643c32b-310e-4888-e063-6394a90ab62f | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | ATLANTIC BIOLOGICALS CORP. | dc8c6638-f487-49df-a265-78caa93e43d8 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee495f20-c668-4d8f-9684-1029a4f232db | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Coupler LLC | 55f3ebec-a742-48fc-e063-6394a90a1452 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | ANI Pharmaceuticals, Inc. | 1f47ec91-602f-4fba-8f7e-a5698760b655 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 03d3b52d-3a7d-4595-84c9-332da6ca9171 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | c84807bd-35d7-4138-8989-42617d69293a | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERDAL | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 7e117c7e-02fc-4343-92a1-230061dfc5e0 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | e72a2768-815f-47bf-b2f9-16a93dd10684 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 50216d94-7667-bd6a-e063-6394a90a8155 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| risperidone | RISPERIDONE | Cardinal Health 107, LLC | 3ce21196-4aa0-469b-8f04-6650b2c48cb5 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Solco Healthcare US, LLC | 43aa2a4f-1123-4f86-800b-9218882f7bcd | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Amici Pharma, Inc. | ca41c144-224a-4d57-88d7-8778e6c69ed2 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.