risperidone

Generic: risperidone

Labeler: jubilant cadista pharmacuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler jubilant cadista pharmacuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 3 mg/1

Manufacturer
Jubilant Cadista Pharmacuticals Inc.

Identifiers & Regulatory

Product NDC 59746-225
Product ID 59746-225_39d41b28-93eb-446b-9652-7432858ccbab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078828
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59746225
Hyphenated Format 59746-225

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UNII
L6UH7ZF8HC
NUI
N0000175430

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name risperidone (source: ndc)
Generic Name risperidone (source: ndc)
Application Number ANDA078828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (59746-225-05)
  • 60 TABLET in 1 BOTTLE (59746-225-60)
source: ndc

Packages (2)

59746-225-05 500 TABLET in 1 BOTTLE (59746-225-05) 59746-225-60 60 TABLET in 1 BOTTLE (59746-225-60)

Ingredients (1)

risperidone (3 mg/1)

Linked Drug Pages (1)

Risperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39d41b28-93eb-446b-9652-7432858ccbab", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["39d41b28-93eb-446b-9652-7432858ccbab"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Jubilant Cadista Pharmacuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (59746-225-05)", "package_ndc": "59746-225-05", "marketing_start_date": "20251015"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (59746-225-60)", "package_ndc": "59746-225-60", "marketing_start_date": "20251015"}], "brand_name": "Risperidone", "product_id": "59746-225_39d41b28-93eb-446b-9652-7432858ccbab", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "59746-225", "generic_name": "Risperidone", "labeler_name": "Jubilant Cadista Pharmacuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA078828", "marketing_category": "ANDA", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}