aripiprazole

Generic: aripiprazole

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler apotex corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

aripiprazole 1 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0404
Product ID 60505-0404_30d65f6a-6da1-4ba2-2eb3-339c2f54a735
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204094
Listing Expiration 2026-12-31
Marketing Start 2015-10-08

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050404
Hyphenated Format 60505-0404

Supplemental Identifiers

RxCUI
485496
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 ANDA204094 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (60505-0404-5) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

60505-0404-5 1 BOTTLE in 1 CARTON (60505-0404-5) / 150 mL in 1 BOTTLE

Ingredients (1)

aripiprazole (1 mg/mL)

Linked Drug Pages (1)

aripiprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30d65f6a-6da1-4ba2-2eb3-339c2f54a735", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["485496"], "spl_set_id": ["14910dae-da81-3d73-d0a4-e98d13917c69"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (60505-0404-5)  / 150 mL in 1 BOTTLE", "package_ndc": "60505-0404-5", "marketing_start_date": "20151008"}], "brand_name": "aripiprazole", "product_id": "60505-0404_30d65f6a-6da1-4ba2-2eb3-339c2f54a735", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60505-0404", "generic_name": "aripiprazole", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "1 mg/mL"}], "application_number": "ANDA204094", "marketing_category": "ANDA", "marketing_start_date": "20151008", "listing_expiration_date": "20261231"}