aripiprazole

Generic: aripiprazole

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler bionpharma inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

aripiprazole 10 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-338
Product ID 69452-338_a104bd7b-2748-450c-b4d3-9e96ccf2939d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202547
Listing Expiration 2026-12-31
Marketing Start 2022-02-07

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452338
Hyphenated Format 69452-338

Supplemental Identifiers

RxCUI
643019 643022
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 ANDA202547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-338-13)
source: ndc

Packages (1)

69452-338-13 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-338-13)

Ingredients (1)

aripiprazole (10 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": "a104bd7b-2748-450c-b4d3-9e96ccf2939d", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["643019", "643022"], "spl_set_id": ["720bc395-777d-4e5d-9571-aad5827dbf6d"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-338-13)", "package_ndc": "69452-338-13", "marketing_start_date": "20220207"}], "brand_name": "Aripiprazole", "product_id": "69452-338_a104bd7b-2748-450c-b4d3-9e96ccf2939d", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69452-338", "generic_name": "Aripiprazole", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA202547", "marketing_category": "ANDA", "marketing_start_date": "20220207", "listing_expiration_date": "20261231"}