risperidone

Generic: risperidone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risperidone 1 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-272
Product ID 68084-272_43e5e95c-ad0c-3657-e063-6394a90af632
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078040
Listing Expiration 2026-12-31
Marketing Start 2008-12-02

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084272
Hyphenated Format 68084-272

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
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 ANDA078040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-272-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-272-11)
source: ndc

Packages (1)

68084-272-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-272-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-272-11)

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": "43e5e95c-ad0c-3657-e063-6394a90af632", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["f11dae15-b057-4258-9229-3819d0c980fe"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-272-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-272-11)", "package_ndc": "68084-272-01", "marketing_start_date": "20081202"}], "brand_name": "Risperidone", "product_id": "68084-272_43e5e95c-ad0c-3657-e063-6394a90af632", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68084-272", "generic_name": "Risperidone", "labeler_name": "American Health Packaging", "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": "20081202", "listing_expiration_date": "20261231"}