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 1 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-908
Product ID 43063-908_32d6d5a1-fa47-3097-e063-6294a90ac4e0
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 43063908
Hyphenated Format 43063-908

Supplemental Identifiers

RxCUI
312830
UPC
0343063908075
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
  • 1 mg/1
source: ndc
Packaging
  • 7 TABLET in 1 BOTTLE, PLASTIC (43063-908-07)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-908-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-908-60)
source: ndc

Packages (3)

43063-908-07 7 TABLET in 1 BOTTLE, PLASTIC (43063-908-07) 43063-908-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-908-30) 43063-908-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-908-60)

Ingredients (1)

risperidone (1 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": "32d6d5a1-fa47-3097-e063-6294a90ac4e0", "openfda": {"nui": ["N0000175430"], "upc": ["0343063908075"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312830"], "spl_set_id": ["be388943-fe0c-4c82-ac8e-3df9f77b2891"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET in 1 BOTTLE, PLASTIC (43063-908-07)", "package_ndc": "43063-908-07", "marketing_start_date": "20220811"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-908-30)", "package_ndc": "43063-908-30", "marketing_start_date": "20181127"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-908-60)", "package_ndc": "43063-908-60", "marketing_start_date": "20181127"}], "brand_name": "RISPERIDONE", "product_id": "43063-908_32d6d5a1-fa47-3097-e063-6294a90ac4e0", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43063-908", "generic_name": "RISPERIDONE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20140328", "listing_expiration_date": "20261231"}