aripiprazole

Generic: aripiprazole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

aripiprazole 2 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-254
Product ID 46708-254_5108607e-5633-4b19-82f9-6c48720960c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202101
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 46708254
Hyphenated Format 46708-254

Supplemental Identifiers

RxCUI
349490 349545 349547 349553 402131 602964
UPC
0346708258306 0346708256302 0346708254308 0346708259303 0346708255305
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 ANDA202101 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (46708-254-10)
  • 30 TABLET in 1 BOTTLE (46708-254-30)
  • 100 TABLET in 1 BOTTLE (46708-254-31)
  • 180 TABLET in 1 BOTTLE (46708-254-45)
  • 60 TABLET in 1 BOTTLE (46708-254-60)
  • 500 TABLET in 1 BOTTLE (46708-254-71)
  • 1000 TABLET in 1 BOTTLE (46708-254-91)
source: ndc

Packages (7)

46708-254-10 100 TABLET in 1 CARTON (46708-254-10) 46708-254-30 30 TABLET in 1 BOTTLE (46708-254-30) 46708-254-31 100 TABLET in 1 BOTTLE (46708-254-31) 46708-254-45 180 TABLET in 1 BOTTLE (46708-254-45) 46708-254-60 60 TABLET in 1 BOTTLE (46708-254-60) 46708-254-71 500 TABLET in 1 BOTTLE (46708-254-71) 46708-254-91 1000 TABLET in 1 BOTTLE (46708-254-91)

Ingredients (1)

aripiprazole (2 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": "5108607e-5633-4b19-82f9-6c48720960c4", "openfda": {"nui": ["N0000175430"], "upc": ["0346708258306", "0346708256302", "0346708254308", "0346708259303", "0346708255305"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["793fc904-2f11-4f97-a0ac-4d6910cac0f9"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (46708-254-10)", "package_ndc": "46708-254-10", "marketing_start_date": "20150428"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-254-30)", "package_ndc": "46708-254-30", "marketing_start_date": "20150428"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-254-31)", "package_ndc": "46708-254-31", "marketing_start_date": "20150428"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (46708-254-45)", "package_ndc": "46708-254-45", "marketing_start_date": "20150428"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (46708-254-60)", "package_ndc": "46708-254-60", "marketing_start_date": "20150428"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-254-71)", "package_ndc": "46708-254-71", "marketing_start_date": "20150428"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-254-91)", "package_ndc": "46708-254-91", "marketing_start_date": "20150428"}], "brand_name": "Aripiprazole", "product_id": "46708-254_5108607e-5633-4b19-82f9-6c48720960c4", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "46708-254", "generic_name": "Aripiprazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "2 mg/1"}], "application_number": "ANDA202101", "marketing_category": "ANDA", "marketing_start_date": "20150428", "listing_expiration_date": "20261231"}