aripiprazole

Generic: aripiprazole

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

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aripiprazole 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7368
Product ID 0904-7368_face01d9-5df3-4581-a4e7-e692444768a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204838
Listing Expiration 2027-12-31
Marketing Start 2016-06-20

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047368
Hyphenated Format 0904-7368

Supplemental Identifiers

RxCUI
349490 349545 349547 349553 402131 602964
UNII
82VFR53I78
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 aripiprazole (source: ndc)
Generic Name aripiprazole (source: ndc)
Application Number ANDA204838 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-7368-06) / 1 TABLET in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-7368-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

0904-7368-06 50 BLISTER PACK in 1 CARTON (0904-7368-06) / 1 TABLET in 1 BLISTER PACK 0904-7368-61 100 BLISTER PACK in 1 CARTON (0904-7368-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

aripiprazole (10 mg/1)

Linked Drug Pages (1)

Aripiprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "face01d9-5df3-4581-a4e7-e692444768a5", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["573c6bb6-941f-4413-8c23-826025385864"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7368-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7368-06", "marketing_start_date": "20231001"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7368-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7368-61", "marketing_start_date": "20231001"}], "brand_name": "Aripiprazole", "product_id": "0904-7368_face01d9-5df3-4581-a4e7-e692444768a5", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-7368", "generic_name": "Aripiprazole", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA204838", "marketing_category": "ANDA", "marketing_start_date": "20160620", "listing_expiration_date": "20271231"}