Aripiprazole

Product NDC
71335-1903
11-digit product format
713351903
Labeler code
71335
Product ID
71335-1903_47ce4019-6896-484c-949e-0c55d23f013c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207105
Marketing category
ANDA
Marketing start
2019-02-27
Substance
ARIPIPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349545

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
71335-1903-1Aripiprazole30 in 1 BOTTLETABLET30105
71335-1903-2Aripiprazole60 in 1 BOTTLETABLET60105
71335-1903-3Aripiprazole28 in 1 BOTTLETABLET28105
71335-1903-4Aripiprazole90 in 1 BOTTLETABLET90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1903-1EA - Each71335-1903fd3ce239-8223-4e75-8920-daaa2aaffe0412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1903ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20240602_1e8d889e-126b-4627-a2cc-34f2d35a5d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN1e8d889e-126b-4627-a2cc-34f2d35a5d67105
349545aripiprazole 10 MG Oral TabletSCD1e8d889e-126b-4627-a2cc-34f2d35a5d67105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1903-17133519030130 TABLET in 1 BOTTLE (71335-1903-1) 30 tablet2021-07-190000-00-00NoNoCurrent
71335-1903-27133519030260 TABLET in 1 BOTTLE (71335-1903-2) 60 tablet2024-04-050000-00-00NoNoCurrent
71335-1903-37133519030328 TABLET in 1 BOTTLE (71335-1903-3) 28 tablet2024-04-050000-00-00NoNoCurrent
71335-1903-47133519030490 TABLET in 1 BOTTLE (71335-1903-4) 90 tablet2022-08-150000-00-00NoNoCurrent