risperidone

Generic: risperidone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-977
Product ID 42291-977_3d4c5818-d71d-e4d0-e063-6394a90a9679
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078707
Listing Expiration 2026-12-31
Marketing Start 2025-08-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291977
Hyphenated Format 42291-977

Supplemental Identifiers

RxCUI
312831 312832 314211
UPC
0342291978508 0342291977501 0342291979505
UNII
L6UH7ZF8HC
NUI
N0000175430

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 ANDA078707 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (42291-977-50)
  • 60 TABLET, FILM COATED in 1 BOTTLE (42291-977-60)
source: ndc

Packages (2)

42291-977-50 500 TABLET, FILM COATED in 1 BOTTLE (42291-977-50) 42291-977-60 60 TABLET, FILM COATED in 1 BOTTLE (42291-977-60)

Ingredients (1)

risperidone (2 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": "3d4c5818-d71d-e4d0-e063-6394a90a9679", "openfda": {"nui": ["N0000175430"], "upc": ["0342291978508", "0342291977501", "0342291979505"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312831", "312832", "314211"], "spl_set_id": ["3d4c51e2-b09b-9fd0-e063-6294a90ae699"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42291-977-50)", "package_ndc": "42291-977-50", "marketing_start_date": "20250827"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42291-977-60)", "package_ndc": "42291-977-60", "marketing_start_date": "20250827"}], "brand_name": "Risperidone", "product_id": "42291-977_3d4c5818-d71d-e4d0-e063-6394a90a9679", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "42291-977", "generic_name": "Risperidone", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA078707", "marketing_category": "ANDA", "marketing_start_date": "20250827", "listing_expiration_date": "20261231"}