aripiprazole

Generic: aripiprazole

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

Drug Facts

Product Profile

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

aripiprazole 15 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-091
Product ID 82009-091_5c525d81-2a40-4c63-a28c-94865bf0c493
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206174
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009091
Hyphenated Format 82009-091

Supplemental Identifiers

RxCUI
349490 349545 402131 602964
UPC
0382009088051 0382009090054 0382009091051 0382009089058
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 ANDA206174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (82009-091-05)
source: ndc

Packages (1)

82009-091-05 500 TABLET in 1 BOTTLE (82009-091-05)

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": "5c525d81-2a40-4c63-a28c-94865bf0c493", "openfda": {"nui": ["N0000175430"], "upc": ["0382009088051", "0382009090054", "0382009091051", "0382009089058"], "unii": ["82VFR53I78"], "rxcui": ["349490", "349545", "402131", "602964"], "spl_set_id": ["0e0d42ad-f4c6-4e30-adc2-ab1d122428ec"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (82009-091-05)", "package_ndc": "82009-091-05", "marketing_start_date": "20230719"}], "brand_name": "Aripiprazole", "product_id": "82009-091_5c525d81-2a40-4c63-a28c-94865bf0c493", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "82009-091", "generic_name": "Aripiprazole", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA206174", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}