aripiprazole

Generic: aripiprazole

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler accord healthcare, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aripiprazole 5 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-279
Product ID 16729-279_40825d37-d601-2272-e063-6294a90af90d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206251
Listing Expiration 2026-12-31
Marketing Start 2017-02-15

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729279
Hyphenated Format 16729-279

Supplemental Identifiers

RxCUI
349490 349545 349547 349553 402131 602964
UNII
82VFR53I78
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 aripiprazole (source: ndc)
Generic Name aripiprazole (source: ndc)
Application Number ANDA206251 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (16729-279-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (16729-279-10)
source: ndc

Packages (2)

Ingredients (1)

aripiprazole (5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "40825d37-d601-2272-e063-6294a90af90d", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["85cc7d25-414b-4b6f-a03a-48af908a16a1"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (16729-279-01)", "package_ndc": "16729-279-01", "marketing_start_date": "20170215"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (16729-279-10)", "package_ndc": "16729-279-10", "marketing_start_date": "20170215"}], "brand_name": "ARIPIPRAZOLE", "product_id": "16729-279_40825d37-d601-2272-e063-6294a90af90d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16729-279", "generic_name": "ARIPIPRAZOLE", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARIPIPRAZOLE", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA206251", "marketing_category": "ANDA", "marketing_start_date": "20170215", "listing_expiration_date": "20261231"}