FDA.reportPublic FDA data

Risperidone

Product NDC
51991-716
11-digit product format
519910716
Labeler code
51991
Product ID
51991-716_0201ab4c-576d-41d1-8b45-4f6375386a2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
SOLUTION
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA079059
Marketing category
ANDA
Marketing start
2014-01-29
Marketing end
2020-11-30
Substance
RISPERIDONE
Active strength
1 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51991-716DDiscontinued by firm2026-07-31
excluded packagepackage51991-71651991-716-41DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079059-001RISPERIDONERISPERIDONE1MG/MLSOLUTION / ORALAA2012-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A079059-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079059-001RISPERIDONE1MG/MLSOLUTION / ORALAA2012-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079059-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEATLANTIC BIOLOGICALS CORP.dc8c6638-f487-49df-a265-78caa93e43d82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079059
application number: ANDA079059
RisperidoneRISPERIDONEREMEDYREPACK INC.8a4158fe-37d4-4c97-9c44-1c3489fe2a9f2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079059
application number: ANDA079059
RisperidoneRISPERIDONEBryant Ranch Prepack4604052d-dbda-4535-b7b8-1bd72a129aca2025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079059
application number: ANDA079059
RisperidoneRISPERIDONECranbury Pharmaceuticals, LLCa0a21bec-68f0-444e-a611-d0602859410c2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079059
application number: ANDA079059
RisperidoneRISPERIDONEBryant Ranch Prepack3cc027f0-3462-4a2f-925b-d8a529bcb3c32025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079059
application number: ANDA079059

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RisperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2
RisperidoneACTIVE MOIETYL6UH7ZF8HCRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Tartaric AcidINACTIVE INGREDIENTW4888I119HRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RRISPERIDONE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]2