risperidone

Generic: risperidone

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

risperidone 2 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4618
Product ID 68071-4618_1ab66f0e-a2a8-09b0-e063-6394a90aec7b
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 680714618
Hyphenated Format 68071-4618

Supplemental Identifiers

RxCUI
312831
UPC
0368071461831
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
  • 30 TABLET in 1 BOTTLE (68071-4618-3)
source: ndc

Packages (1)

68071-4618-3 30 TABLET in 1 BOTTLE (68071-4618-3)

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": "1ab66f0e-a2a8-09b0-e063-6394a90aec7b", "openfda": {"nui": ["N0000175430"], "upc": ["0368071461831"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312831"], "spl_set_id": ["79648a52-1364-c25b-e053-2a91aa0a8ea4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-4618-3)", "package_ndc": "68071-4618-3", "marketing_start_date": "20181029"}], "brand_name": "RISPERIDONE", "product_id": "68071-4618_1ab66f0e-a2a8-09b0-e063-6394a90aec7b", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68071-4618", "generic_name": "RISPERIDONE", "labeler_name": "NuCare 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"}