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 | Proficient Rx LP | 1b5c9889-4dc3-48df-8629-4ac099e2b4c0 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Sun Pharmaceutical Industries, Inc. | f91f551e-926f-440d-83d2-357e9d7484fe | 2022-07-13 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 394c7e27-52a2-4d4c-8c6e-fe37b03266ae | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| risperidone | RISPERIDONE | Proficient Rx LP | b611fe52-1787-47e6-8a6b-1999a4e4f22c | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | ac152803-d75f-4c3c-bc49-8663b21a3a82 | 2019-04-29 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
| Risperidone | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | 58e422ec-da66-41b0-83c1-aefd940beda0 | 2019-04-10 | Boxed warning, Warnings, Adverse reactions | L6UH7ZF8HC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.