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 table
LabelManufacturerEffective dateType
PERSERISIndivior 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.2025-01-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12496-0776PERSERIS (RISPERIDONE) KIT [INDIVIOR INC.]18Unmatched20250221_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.

Matched openFDA labels page 2 of 4 · 66 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONETorrent Pharmaceuticals Limiteda6347895-5f16-43b4-92a0-b9904ac819372026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEREMEDYREPACK INC.2776a647-678d-465c-9db3-4a9459ce779e2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEREMEDYREPACK INC.5d9519af-5a5e-47ce-8a0f-9b9cfac00e192026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee7d6779-7421-4761-99d2-ccbfde9385a82026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEREMEDYREPACK INC.101b2d4d-4740-4225-94bc-aecc05d82c6b2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEPar Health USA, LLCd0ef6df3-67e5-47b1-bcf7-f67aa030caca2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
risperidoneRISPERIDONEMajor Pharmaceuticalsd5abd75f-7f4a-4a7d-b849-82fce88f5ff72026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEWestminster Pharmaceuticals, LLC07d43bf6-a695-453a-a5c7-9581effe585c2025-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEGolden State Medical Supply, Inc.448467a3-44ef-c87b-e063-6294a90a5ec92025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEAmerican Health Packagingf11dae15-b057-4258-9229-3819d0c980fe2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEJubilant Cadista Pharmacuticals Inc.739dcf8a-ed73-5eb0-899b-7e51cb73c3352025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEAjanta Pharma USA Inc.095630bd-a77e-434e-94ee-f13da445d8f22025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEAvKARE3d4c51e2-b09b-9fd0-e063-6294a90ae6992025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEBryant Ranch Prepack4604052d-dbda-4535-b7b8-1bd72a129aca2025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONENuCare Pharmaceuticals, Inc.390904c2-fcfa-466e-e063-6394a90a03af2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEJubilant Cadista Pharmacuticals Inc.39d41b28-93eb-446b-9652-7432858ccbab2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
risperidoneRISPERIDONEZydus Pharmaceuticals USA Inc.713b5ac7-53d6-4139-8599-3028f789de4b2025-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEBryant Ranch Prepack684dcda4-d270-400c-9798-7d920a038bbb2025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONECranbury Pharmaceuticals, LLCa0a21bec-68f0-444e-a611-d0602859410c2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.be388943-fe0c-4c82-ac8e-3df9f77b28912025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.