risperidone

Generic: risperidone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0459
Product ID 71335-0459_25191912-fb7b-4b6a-bf49-3956ef044e96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201003
Listing Expiration 2026-12-31
Marketing Start 2014-03-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350459
Hyphenated Format 71335-0459

Supplemental Identifiers

RxCUI
312831
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
  • 2 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71335-0459-1)
  • 30 TABLET in 1 BOTTLE (71335-0459-2)
  • 90 TABLET in 1 BOTTLE (71335-0459-3)
source: ndc

Packages (3)

71335-0459-1 60 TABLET in 1 BOTTLE (71335-0459-1) 71335-0459-2 30 TABLET in 1 BOTTLE (71335-0459-2) 71335-0459-3 90 TABLET in 1 BOTTLE (71335-0459-3)

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": "25191912-fb7b-4b6a-bf49-3956ef044e96", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312831"], "spl_set_id": ["420cfeef-0061-43b9-9491-dbd6ad866e55"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-0459-1)", "package_ndc": "71335-0459-1", "marketing_start_date": "20190314"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-0459-2)", "package_ndc": "71335-0459-2", "marketing_start_date": "20180712"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-0459-3)", "package_ndc": "71335-0459-3", "marketing_start_date": "20240529"}], "brand_name": "RISPERIDONE", "product_id": "71335-0459_25191912-fb7b-4b6a-bf49-3956ef044e96", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71335-0459", "generic_name": "RISPERIDONE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20140328", "listing_expiration_date": "20261231"}