opipza

Generic: aripiprazole

Labeler: carwin pharmaceutical associates, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name opipza
Generic Name aripiprazole
Labeler carwin pharmaceutical associates, llc
Dosage Form FILM, SOLUBLE
Routes
ORAL
Active Ingredients

aripiprazole 2 mg/1

Manufacturer
Carwin Pharmaceutical Associates, LLC

Identifiers & Regulatory

Product NDC 15370-401
Product ID 15370-401_3dbb4e6d-14f0-4668-877c-2f4d9a94751f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216655
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 15370401
Hyphenated Format 15370-401

Supplemental Identifiers

RxCUI
2697158 2697164 2697165 2697167 2697168 2697170
UPC
0315370403307 0315370402300 0315370401303
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 opipza (source: ndc)
Generic Name aripiprazole (source: ndc)
Application Number NDA216655 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01)
  • 2 POUCH in 1 CARTON (15370-401-99) / 1 FILM, SOLUBLE in 1 POUCH
source: ndc

Packages (2)

15370-401-30 30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) 15370-401-99 2 POUCH in 1 CARTON (15370-401-99) / 1 FILM, SOLUBLE in 1 POUCH

Ingredients (1)

aripiprazole (2 mg/1)

Linked Drug Pages (1)

OPIPZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3dbb4e6d-14f0-4668-877c-2f4d9a94751f", "openfda": {"nui": ["N0000175430"], "upc": ["0315370403307", "0315370402300", "0315370401303"], "unii": ["82VFR53I78"], "rxcui": ["2697158", "2697164", "2697165", "2697167", "2697168", "2697170"], "spl_set_id": ["b47ede68-8942-4432-af7e-57afc14b2ba4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Carwin Pharmaceutical Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (15370-401-30)  / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01)", "package_ndc": "15370-401-30", "marketing_start_date": "20241101"}, {"sample": true, "description": "2 POUCH in 1 CARTON (15370-401-99)  / 1 FILM, SOLUBLE in 1 POUCH", "package_ndc": "15370-401-99", "marketing_start_date": "20250128"}], "brand_name": "OPIPZA", "product_id": "15370-401_3dbb4e6d-14f0-4668-877c-2f4d9a94751f", "dosage_form": "FILM, SOLUBLE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "15370-401", "generic_name": "ARIPIPRAZOLE", "labeler_name": "Carwin Pharmaceutical Associates, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPIPZA", "active_ingredients": [{"name": "ARIPIPRAZOLE", "strength": "2 mg/1"}], "application_number": "NDA216655", "marketing_category": "NDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}