aripiprazole

Generic: aripiprazole

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

Drug Facts

Product Profile

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

aripiprazole 15 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-125
Product ID 33342-125_deb9183f-bf62-4547-9c33-b6d8af55ddd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204111
Listing Expiration 2026-12-31
Marketing Start 2016-10-08

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342125
Hyphenated Format 33342-125

Supplemental Identifiers

RxCUI
349490 349545 349547 349553 402131 602964
UPC
0333342126078 0333342123077 0333342125071 0333342122070 0333342124074 0333342127075
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 ANDA204111 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-125-07)
  • 100 TABLET in 1 BOTTLE (33342-125-11)
  • 10 BLISTER PACK in 1 CARTON (33342-125-12) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

33342-125-07 30 TABLET in 1 BOTTLE (33342-125-07) 33342-125-11 100 TABLET in 1 BOTTLE (33342-125-11) 33342-125-12 10 BLISTER PACK in 1 CARTON (33342-125-12) / 10 TABLET in 1 BLISTER PACK

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": "deb9183f-bf62-4547-9c33-b6d8af55ddd9", "openfda": {"nui": ["N0000175430"], "upc": ["0333342126078", "0333342123077", "0333342125071", "0333342122070", "0333342124074", "0333342127075"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "349547", "349553", "402131", "602964"], "spl_set_id": ["ab4245a1-71f7-45be-a2ef-b0636ed3cc20"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-125-07)", "package_ndc": "33342-125-07", "marketing_start_date": "20161008"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-125-11)", "package_ndc": "33342-125-11", "marketing_start_date": "20161008"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-125-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-125-12", "marketing_start_date": "20161008"}], "brand_name": "Aripiprazole", "product_id": "33342-125_deb9183f-bf62-4547-9c33-b6d8af55ddd9", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "33342-125", "generic_name": "Aripiprazole", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA204111", "marketing_category": "ANDA", "marketing_start_date": "20161008", "listing_expiration_date": "20261231"}