aripiprazole

Generic: aripiprazole

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

Drug Facts

Product Profile

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

aripiprazole 10 mg/1

Manufacturer
Viona Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72578-106
Product ID 72578-106_62486381-abea-40d9-aa88-bf3f3665a65f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090165
Listing Expiration 2026-12-31
Marketing Start 2022-07-20

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578106
Hyphenated Format 72578-106

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 ANDA090165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06)
  • 3 BLISTER PACK in 1 CARTON (72578-106-78) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30)
source: ndc

Packages (2)

72578-106-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06) 72578-106-78 3 BLISTER PACK in 1 CARTON (72578-106-78) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30)

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": "62486381-abea-40d9-aa88-bf3f3665a65f", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["643019", "643022"], "spl_set_id": ["73c5e380-b7b1-4362-a827-71881574ff48"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06)", "package_ndc": "72578-106-06", "marketing_start_date": "20220720"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (72578-106-78)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30)", "package_ndc": "72578-106-78", "marketing_start_date": "20230222"}], "brand_name": "Aripiprazole", "product_id": "72578-106_62486381-abea-40d9-aa88-bf3f3665a65f", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72578-106", "generic_name": "Aripiprazole", "labeler_name": "Viona Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA090165", "marketing_category": "ANDA", "marketing_start_date": "20220720", "listing_expiration_date": "20261231"}