risperidone

Generic: risperidone

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 3 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-525
Product ID 72189-525_2c4e8272-05a2-1cc7-e063-6394a90a3371
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201003
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189525
Hyphenated Format 72189-525

Supplemental Identifiers

RxCUI
312832
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
  • 3 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-525-60)
source: ndc

Packages (1)

72189-525-60 60 TABLET in 1 BOTTLE (72189-525-60)

Ingredients (1)

risperidone (3 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": "2c4e8272-05a2-1cc7-e063-6394a90a3371", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312832"], "spl_set_id": ["0b784f21-fc02-6542-e063-6294a90a285e"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-525-60)", "package_ndc": "72189-525-60", "marketing_start_date": "20231201"}], "brand_name": "Risperidone", "product_id": "72189-525_2c4e8272-05a2-1cc7-e063-6394a90a3371", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72189-525", "generic_name": "Risperidone", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}