risperidone

Generic: risperidone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone .5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-642
Product ID 63187-642_e3793e49-cf4b-4bf3-a89a-bd9deaf2be61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201003
Listing Expiration 2026-12-31
Marketing Start 2015-09-09

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187642
Hyphenated Format 63187-642

Supplemental Identifiers

RxCUI
312829
UPC
0363187642303
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 ANDA201003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-642-30)
  • 60 TABLET in 1 BOTTLE (63187-642-60)
  • 90 TABLET in 1 BOTTLE (63187-642-90)
source: ndc

Packages (3)

63187-642-30 30 TABLET in 1 BOTTLE (63187-642-30) 63187-642-60 60 TABLET in 1 BOTTLE (63187-642-60) 63187-642-90 90 TABLET in 1 BOTTLE (63187-642-90)

Ingredients (1)

risperidone (.5 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": "e3793e49-cf4b-4bf3-a89a-bd9deaf2be61", "openfda": {"nui": ["N0000175430"], "upc": ["0363187642303"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312829"], "spl_set_id": ["1b5c9889-4dc3-48df-8629-4ac099e2b4c0"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-642-30)", "package_ndc": "63187-642-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-642-60)", "package_ndc": "63187-642-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-642-90)", "package_ndc": "63187-642-90", "marketing_start_date": "20181201"}], "brand_name": "RISPERIDONE", "product_id": "63187-642_e3793e49-cf4b-4bf3-a89a-bd9deaf2be61", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63187-642", "generic_name": "RISPERIDONE", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": ".5 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20150909", "listing_expiration_date": "20261231"}