FDA.reportPublic FDA data

Acarbose

Product NDC
71335-9725
11-digit product format
713359725
Labeler code
71335
Product ID
71335-9725_5b695702-3a0b-4370-a452-7894329970ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acarbose
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202271
Marketing category
ANDA
Marketing start
2021-04-16
Substance
ACARBOSE
Active strength
50 mg/1
Pharmacologic classes
alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACARBOSE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT58MSI464G
Rxcui199149

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2712f130-8721-1a9d-6846-53893b13fb67Product name220210312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9725-1Acarbose30 in 1 BOTTLETABLET30101
71335-9725-2Acarbose90 in 1 BOTTLETABLET90101
71335-9725-3Acarbose100 in 1 BOTTLETABLET100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9725ACARBOSE TABLET [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20240829_067c0adc-7322-489d-9baa-1d061b37be36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199149acarbose 50 MG Oral TabletPSN067c0adc-7322-489d-9baa-1d061b37be36101
199149acarbose 50 MG Oral TabletSCD067c0adc-7322-489d-9baa-1d061b37be36101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9725-17133597250130 TABLET in 1 BOTTLE (71335-9725-1) 30 tablet2023-09-11NoNoHistorical
71335-9725-27133597250290 TABLET in 1 BOTTLE (71335-9725-2) 90 tablet2024-08-12NoNoHistorical
71335-9725-371335972503100 TABLET in 1 BOTTLE (71335-9725-3) 100 tablet2024-08-12NoNoHistorical