Home NDC 59746-040 Risperidone
Product NDC 59746-040
11-digit product format 597460040
Labeler code 59746
Product ID 59746-040_90b80768-87f7-4fb1-8142-909dba9555e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risperidone
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler Jubilant Cadista Pharmacuticals Inc.
Application ANDA090839
Marketing category ANDA
Marketing start 2011-11-04
Substance RISPERIDONE
Active strength 3 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090839-001 RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 A090839-002 RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 A090839-003 RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 A090839-004 RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 A090839-005 RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A090839-001 RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A090839-002 RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING / ORAL AB RS 2011-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A090839-003 RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A090839-004 RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A090839-005 RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2011-11-04 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Risperidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISPERIDONE 3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L6UH7ZF8HC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 401953 Internal RxNorm lookup 401954 Internal RxNorm lookup 403825 Internal RxNorm lookup 616698 Internal RxNorm lookup 616705 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59746-040-22 Risperidone 4 in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING 4 25 59746-040-22 Risperidone 7 in 1 CARTON TABLET, ORALLY DISINTEGRATING 7 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Risperidone ACTIVE INGREDIENT L6UH7ZF8HC RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Risperidone ACTIVE MOIETY L6UH7ZF8HC RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Acesulfame Potassium INACTIVE INGREDIENT 23OV73Q5G9 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Aspartame INACTIVE INGREDIENT Z0H242BBR1 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer INACTIVE INGREDIENT 905HNO1SIH RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Fd&c Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Fd&c Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Hydroxypropyl Cellulose, Low Substituted INACTIVE INGREDIENT 2165RE0K14 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Magnesium Aluminometasilicate Type I-a INACTIVE INGREDIENT 7LVU907546 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Mannitol INACTIVE INGREDIENT 3OWL53L36A RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Peppermint INACTIVE INGREDIENT V95R5KMY2B RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Sodium Stearyl Fumarate INACTIVE INGREDIENT 7CV7WJK4UI RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11 Talc INACTIVE INGREDIENT 7SEV7J4R1U RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-040 RISPERIDONE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.] 24 Current NDC, Legacy NDC, 2 package rows 20250519_739dcf8a-ed73-5eb0-899b-7e51cb73c335.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-040-22 59746004022 7 BLISTER PACK in 1 CARTON (59746-040-22) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 7 blister pack 2011-11-04 0000-00-00 No No Current