NDC 12496-0776 - 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
- 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 | Bryant Ranch Prepack | 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | AvKARE | 2f9ea0cc-b86b-a11f-e063-6294a90a9620 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | c4582bdf-5eda-438c-98b4-0517500501e8 | 2025-03-04 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Amneal Pharmaceuticals NY LLC | e90c886c-132a-4df6-8604-cfe5ffa49d5b | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Amneal Pharmaceuticals LLC | bc55f60a-8121-44bb-bdfc-1d311879ba4f | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| 2893c2b5-aa3e-4ec7-bfd3-0132306a31a9 | a4f21b1a-5691-4b14-a56d-651962d06f39 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 2893c2b5-aa3e-4ec7-bfd3-0132306a31a9 a4f21b1a-5691-4b14-a56d-651962d06f39 | ||
| Risperidone | RISPERIDONE | Direct_Rx | 0b784f21-fc02-6542-e063-6294a90a285e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| risperidone | RISPERIDONE | Zydus Lifesciences Limited | 23993d21-80bf-41c4-b57d-88a620173b6b | 2024-08-12 | L6UH7ZF8HC | |
| RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | 79648a52-1364-c25b-e053-2a91aa0a8ea4 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 420cfeef-0061-43b9-9491-dbd6ad866e55 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | aab773b2-a605-4cf8-a301-57e390fe67a6 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 2f83d3e9-04ab-4b24-ad1f-7ed2e784298a | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | e35be034-6275-41fb-bec4-9ae451458701 | 2024-04-11 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Chartwell RX, LLC | 12a479c4-a84a-4308-b89f-be0315826fd5 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | 523d4f99-1d6f-413f-9d6e-2ca430aaac14 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Chartwell RX, LLC | 66390528-7517-452a-ae76-4338ec7db3ae | 2023-10-06 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | NCS HealthCare of KY, LLC dba Vangard Labs | 7bbc37f1-6d6a-4021-8976-1f103ce1cfbd | 2023-02-27 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | bda104ac-1eea-4a1a-836a-24bcc034b90f | 2022-11-09 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 088dc3dd-7740-471b-8c06-5a47900ae5b5 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.