risperidone

Generic: risperidone

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7363
Product ID 0904-7363_41d98aaf-a69e-414d-af3f-2c815cd1f43a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078040
Listing Expiration 2027-12-31
Marketing Start 2008-11-13

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047363
Hyphenated Format 0904-7363

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
  • 2 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7363-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7363-61 100 BLISTER PACK in 1 CARTON (0904-7363-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "41d98aaf-a69e-414d-af3f-2c815cd1f43a", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["d5abd75f-7f4a-4a7d-b849-82fce88f5ff7"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7363-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7363-61", "marketing_start_date": "20231027"}], "brand_name": "risperidone", "product_id": "0904-7363_41d98aaf-a69e-414d-af3f-2c815cd1f43a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-7363", "generic_name": "risperidone", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA078040", "marketing_category": "ANDA", "marketing_start_date": "20081113", "listing_expiration_date": "20271231"}