aripiprazole

Generic: aripiprazole

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler exelan pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aripiprazole 15 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-047
Product ID 76282-047_ae9e2824-8741-4973-b349-a18ce05cb334
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205064
Listing Expiration 2026-12-31
Marketing Start 2015-04-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282047
Hyphenated Format 76282-047

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 ANDA205064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76282-047-01)
  • 30 TABLET in 1 BOTTLE (76282-047-30)
source: ndc

Packages (2)

76282-047-01 100 TABLET in 1 BOTTLE (76282-047-01) 76282-047-30 30 TABLET in 1 BOTTLE (76282-047-30)

Ingredients (1)

aripiprazole (15 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": "ae9e2824-8741-4973-b349-a18ce05cb334", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["705190bf-9f9d-4183-a56b-4eeafeacde59"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76282-047-01)", "package_ndc": "76282-047-01", "marketing_start_date": "20161007"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76282-047-30)", "package_ndc": "76282-047-30", "marketing_start_date": "20161007"}], "brand_name": "Aripiprazole", "product_id": "76282-047_ae9e2824-8741-4973-b349-a18ce05cb334", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "76282-047", "generic_name": "Aripiprazole", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA205064", "marketing_category": "ANDA", "marketing_start_date": "20150428", "listing_expiration_date": "20261231"}