aripiprazole

Generic: aripiprazole

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

Drug Facts

Product Profile

Brand Name aripiprazole
Generic Name aripiprazole
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

aripiprazole 15 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-261
Product ID 46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202102
Listing Expiration 2026-12-31
Marketing Start 2015-05-21

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708261
Hyphenated Format 46708-261

Supplemental Identifiers

RxCUI
643019 643022
UPC
0346708261108 0346708260101
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 ANDA202102 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10)
source: ndc

Packages (1)

46708-261-10 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10)

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": "1ea06df8-17dc-46eb-921a-2b52d41ea622", "openfda": {"nui": ["N0000175430"], "upc": ["0346708261108", "0346708260101"], "unii": ["82VFR53I78"], "rxcui": ["643019", "643022"], "spl_set_id": ["4f1691a8-724e-430d-9bab-27b59ef9bd4e"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10)", "package_ndc": "46708-261-10", "marketing_start_date": "20150521"}], "brand_name": "Aripiprazole", "product_id": "46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "46708-261", "generic_name": "Aripiprazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aripiprazole", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA202102", "marketing_category": "ANDA", "marketing_start_date": "20150521", "listing_expiration_date": "20261231"}