risperidone

Generic: risperidone

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risperidone 1 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-114
Product ID 68382-114_2af53e64-46a6-4b12-9ac8-8f8031a8bd97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078040
Listing Expiration 2026-12-31
Marketing Start 2008-11-13

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382114
Hyphenated Format 68382-114

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UNII
L6UH7ZF8HC
NUI
N0000175430

Packaging Origin

Original Packager
true

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 ANDA078040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-114-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-114-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-114-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-114-10)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68382-114-14)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-114-16)
source: ndc

Packages (6)

68382-114-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-114-01) 68382-114-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-114-05) 68382-114-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-114-06) 68382-114-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-114-10) 68382-114-14 60 TABLET, FILM COATED in 1 BOTTLE (68382-114-14) 68382-114-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-114-16)

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": "2af53e64-46a6-4b12-9ac8-8f8031a8bd97", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["713b5ac7-53d6-4139-8599-3028f789de4b"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-114-01)", "package_ndc": "68382-114-01", "marketing_start_date": "20081113"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-114-05)", "package_ndc": "68382-114-05", "marketing_start_date": "20081113"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-114-06)", "package_ndc": "68382-114-06", "marketing_start_date": "20081113"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-114-10)", "package_ndc": "68382-114-10", "marketing_start_date": "20081113"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68382-114-14)", "package_ndc": "68382-114-14", "marketing_start_date": "20081113"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-114-16)", "package_ndc": "68382-114-16", "marketing_start_date": "20081113"}], "brand_name": "risperidone", "product_id": "68382-114_2af53e64-46a6-4b12-9ac8-8f8031a8bd97", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68382-114", "generic_name": "risperidone", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/1"}], "application_number": "ANDA078040", "marketing_category": "ANDA", "marketing_start_date": "20081113", "listing_expiration_date": "20261231"}