FDA.reportPublic FDA data

OPIPZA

Product NDC
15370-401
11-digit product format
153700401
Labeler code
15370
Product ID
15370-401_3dbb4e6d-14f0-4668-877c-2f4d9a94751f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
FILM, SOLUBLE
Route
ORAL
Labeler
Carwin Pharmaceutical Associates, LLC
Application
NDA216655
Marketing category
NDA
Marketing start
2024-11-01
Substance
ARIPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OPIPZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui2697158, 2697164, 2697165, 2697167, 2697168, 2697170

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15370-401-01OPIPZA1 in 1 POUCHFILM, SOLUBLE12
15370-401-30OPIPZA30 in 1 CARTONFILM, SOLUBLE302
15370-401-99OPIPZA1 in 1 POUCHFILM, SOLUBLE12
15370-401-99OPIPZA2 in 1 CARTONFILM, SOLUBLE22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-401-01EA - Each15370-40141f0d1ac-3fde-445a-8b5c-83f0f085fbbb12025-02-10
15370-401-30EA - Each15370-401e36ea9e8-77f1-48e7-a065-8c4b5d35097712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15370-401OPIPZA (ARIPIPRAZOLE) FILM, SOLUBLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]2Current NDC, 4 package rows20250131_b47ede68-8942-4432-af7e-57afc14b2ba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2697168ARIPiprazole 10 MG Oral FilmPSNb47ede68-8942-4432-af7e-57afc14b2ba42
2697158ARIPiprazole 2 MG Oral FilmPSNb47ede68-8942-4432-af7e-57afc14b2ba42
2697165ARIPiprazole 5 MG Oral FilmPSNb47ede68-8942-4432-af7e-57afc14b2ba42
2697170OPIPZA 10 MG Oral FilmPSNb47ede68-8942-4432-af7e-57afc14b2ba42
2697164OPIPZA 2 MG Oral FilmPSNb47ede68-8942-4432-af7e-57afc14b2ba42
2697167OPIPZA 5 MG Oral FilmPSNb47ede68-8942-4432-af7e-57afc14b2ba42
2697170aripiprazole 10 MG Oral Film [Opipza]SBDb47ede68-8942-4432-af7e-57afc14b2ba42
2697164aripiprazole 2 MG Oral Film [Opipza]SBDb47ede68-8942-4432-af7e-57afc14b2ba42
2697167aripiprazole 5 MG Oral Film [Opipza]SBDb47ede68-8942-4432-af7e-57afc14b2ba42
2697168aripiprazole 10 MG Oral FilmSCDb47ede68-8942-4432-af7e-57afc14b2ba42
2697158aripiprazole 2 MG Oral FilmSCDb47ede68-8942-4432-af7e-57afc14b2ba42
2697165aripiprazole 5 MG Oral FilmSCDb47ede68-8942-4432-af7e-57afc14b2ba42
2697170Opipza 10 MG Oral FilmSYb47ede68-8942-4432-af7e-57afc14b2ba42
2697164Opipza 2 MG Oral FilmSYb47ede68-8942-4432-af7e-57afc14b2ba42
2697167Opipza 5 MG Oral FilmSYb47ede68-8942-4432-af7e-57afc14b2ba42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15370-401-01153700401011 in 1 POUCHHistorical
15370-401-301537004013030 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) 30 pouch2024-11-01NoNoHistorical
15370-401-99153700401992 POUCH in 1 CARTON (15370-401-99) / 1 FILM, SOLUBLE in 1 POUCH2 pouch2025-01-28YesNoHistorical