aripiprazole

Generic: aripiprazole

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

aripiprazole 20 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-901
Product ID 65162-901_5542550f-333a-4c31-9430-ffef95401cc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204838
Listing Expiration 2026-12-31
Marketing Start 2016-06-20

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162901
Hyphenated Format 65162-901

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 ANDA204838 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-901-03)
  • 90 TABLET in 1 BOTTLE (65162-901-09)
  • 1000 TABLET in 1 BOTTLE (65162-901-11)
  • 500 TABLET in 1 BOTTLE (65162-901-50)
source: ndc

Packages (4)

65162-901-03 30 TABLET in 1 BOTTLE (65162-901-03) 65162-901-09 90 TABLET in 1 BOTTLE (65162-901-09) 65162-901-11 1000 TABLET in 1 BOTTLE (65162-901-11) 65162-901-50 500 TABLET in 1 BOTTLE (65162-901-50)

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": "5542550f-333a-4c31-9430-ffef95401cc5", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["06dda03f-8481-46d6-af02-4f51e1a3a065"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-901-03)", "package_ndc": "65162-901-03", "marketing_start_date": "20160620"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-901-09)", "package_ndc": "65162-901-09", "marketing_start_date": "20160620"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-901-11)", "package_ndc": "65162-901-11", "marketing_start_date": "20160620"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-901-50)", "package_ndc": "65162-901-50", "marketing_start_date": "20160620"}], "brand_name": "Aripiprazole", "product_id": "65162-901_5542550f-333a-4c31-9430-ffef95401cc5", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65162-901", "generic_name": "Aripiprazole", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA204838", "marketing_category": "ANDA", "marketing_start_date": "20160620", "listing_expiration_date": "20261231"}