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, FILM COATED
Routes
ORAL
Active Ingredients

risperidone .25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-418
Product ID 63187-418_71435439-971d-4db3-89d2-71b74b10f57c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078040
Listing Expiration 2026-12-31
Marketing Start 2008-11-13

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187418
Hyphenated Format 63187-418

Supplemental Identifiers

RxCUI
312828
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 ANDA078040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-418-60)
source: ndc

Packages (1)

63187-418-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-418-60)

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": "71435439-971d-4db3-89d2-71b74b10f57c", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828"], "spl_set_id": ["b611fe52-1787-47e6-8a6b-1999a4e4f22c"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-418-60)", "package_ndc": "63187-418-60", "marketing_start_date": "20190101"}], "brand_name": "risperidone", "product_id": "63187-418_71435439-971d-4db3-89d2-71b74b10f57c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63187-418", "generic_name": "risperidone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": ".25 mg/1"}], "application_number": "ANDA078040", "marketing_category": "ANDA", "marketing_start_date": "20081113", "listing_expiration_date": "20261231"}