aripiprazole

Generic: aripiprazole

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

Drug Facts

Product Profile

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

aripiprazole 10 mg/1

Manufacturer
SQUARE PHARMACEUTICALS LIMITED

Identifiers & Regulatory

Product NDC 76483-100
Product ID 76483-100_d7622fbb-a43c-46db-bde4-d05ed7bff185
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 76483100
Hyphenated Format 76483-100

Supplemental Identifiers

RxCUI
643019 643022 643027 643058
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 (76483-100-00)
  • 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-01)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-02)
  • 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-03)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-100-04)
source: ndc

Packages (5)

76483-100-00 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-00) 76483-100-01 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-01) 76483-100-02 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-02) 76483-100-03 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-03) 76483-100-04 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-100-04)

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": "d7622fbb-a43c-46db-bde4-d05ed7bff185", "openfda": {"nui": ["N0000175430"], "unii": ["82VFR53I78"], "rxcui": ["643019", "643022", "643027", "643058"], "spl_set_id": ["0f9b1fd8-a648-45c9-8655-14de07439f34"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["SQUARE PHARMACEUTICALS LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-00)", "package_ndc": "76483-100-00", "marketing_start_date": "20220720"}, {"sample": false, "description": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-01)", "package_ndc": "76483-100-01", "marketing_start_date": "20220720"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-02)", "package_ndc": "76483-100-02", "marketing_start_date": "20220720"}, {"sample": false, "description": "120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-03)", "package_ndc": "76483-100-03", "marketing_start_date": "20220720"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-100-04)", "package_ndc": "76483-100-04", "marketing_start_date": "20230222"}], "brand_name": "Aripiprazole", "product_id": "76483-100_d7622fbb-a43c-46db-bde4-d05ed7bff185", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "76483-100", "generic_name": "Aripiprazole", "labeler_name": "SQUARE PHARMACEUTICALS LIMITED", "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"}