aripiprazole

Generic: aripiprazole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

aripiprazole 20 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-091
Product ID 50268-091_3d49db38-3629-6bb9-e063-6294a90a4b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205064
Listing Expiration 2026-12-31
Marketing Start 2016-04-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268091
Hyphenated Format 50268-091

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 ANDA205064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-091-12) / 1 TABLET in 1 BLISTER PACK (50268-091-11)
source: ndc

Packages (1)

50268-091-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-091-12) / 1 TABLET in 1 BLISTER PACK (50268-091-11)

Ingredients (1)

aripiprazole (20 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": "3d49db38-3629-6bb9-e063-6294a90a4b4a", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["7df4c83e-13d8-25b1-57eb-08d26ba03565"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-091-12)  / 1 TABLET in 1 BLISTER PACK (50268-091-11)", "package_ndc": "50268-091-12", "marketing_start_date": "20160428"}], "brand_name": "Aripiprazole", "product_id": "50268-091_3d49db38-3629-6bb9-e063-6294a90a4b4a", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50268-091", "generic_name": "Aripiprazole", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA205064", "marketing_category": "ANDA", "marketing_start_date": "20160428", "listing_expiration_date": "20261231"}