risperidone

Generic: risperidone

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risperidone .25 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-368
Product ID 69367-368_4559701f-b153-5434-e063-6294a90a6d1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078707
Listing Expiration 2026-12-31
Marketing Start 2024-09-09

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367368
Hyphenated Format 69367-368

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UPC
0369367369053 0369367373050 0369367368056 0369367372053
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 ANDA078707 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-60)
source: ndc

Packages (2)

69367-368-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-05) 69367-368-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-60)

Ingredients (1)

risperidone (.25 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": "4559701f-b153-5434-e063-6294a90a6d1d", "openfda": {"nui": ["N0000175430"], "upc": ["0369367369053", "0369367373050", "0369367368056", "0369367372053"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["07d43bf6-a695-453a-a5c7-9581effe585c"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-05)", "package_ndc": "69367-368-05", "marketing_start_date": "20240909"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-60)", "package_ndc": "69367-368-60", "marketing_start_date": "20240909"}], "brand_name": "Risperidone", "product_id": "69367-368_4559701f-b153-5434-e063-6294a90a6d1d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69367-368", "generic_name": "Risperidone", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": ".25 mg/1"}], "application_number": "ANDA078707", "marketing_category": "ANDA", "marketing_start_date": "20240909", "listing_expiration_date": "20261231"}