risperidone

Generic: risperidone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-461
Product ID 72789-461_34196d14-2eff-cf33-e063-6394a90ac01e
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 72789461
Hyphenated Format 72789-461

Supplemental Identifiers

RxCUI
312831
UPC
0372789461144
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
  • 14 TABLET in 1 BOTTLE, PLASTIC (72789-461-14)
source: ndc

Packages (1)

72789-461-14 14 TABLET in 1 BOTTLE, PLASTIC (72789-461-14)

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": "34196d14-2eff-cf33-e063-6394a90ac01e", "openfda": {"nui": ["N0000175430"], "upc": ["0372789461144"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312831"], "spl_set_id": ["bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (72789-461-14)", "package_ndc": "72789-461-14", "marketing_start_date": "20241223"}], "brand_name": "RISPERIDONE", "product_id": "72789-461_34196d14-2eff-cf33-e063-6394a90ac01e", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72789-461", "generic_name": "RISPERIDONE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}