FDA.reportPublic FDA data

Acarbose

Product NDC
72789-133
11-digit product format
727890133
Labeler code
72789
Product ID
72789-133_2c2501a6-a6d6-1d6c-e063-6294a90ad428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acarbose
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078470
Marketing category
ANDA
Marketing start
2008-05-07
Substance
ACARBOSE
Active strength
100 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
ACARBOSE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT58MSI464G
Rxcui199149, 199150, 200132

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
72789-133-30Acarbose30 in 1 BOTTLE, PLASTICTABLET3028
72789-133-60Acarbose60 in 1 BOTTLE, PLASTICTABLET6028
72789-133-90Acarbose90 in 1 BOTTLE, PLASTICTABLET9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-133-30EA - Each72789-1336df125db-41ac-43d0-9233-a0e6828412ce12023-08-08
72789-133-90EA - Each72789-1331e72b852-24ac-4b4f-9519-6dc9cd885aeb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-133ACARBOSE TABLET [PD-RX PHARMACEUTICALS, INC.]28Current NDC, Legacy NDC, 3 package rows20250121_722ce9eb-8f7b-4651-a287-d53dd7ab3707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199150acarbose 100 MG Oral TabletPSN722ce9eb-8f7b-4651-a287-d53dd7ab370728
200132acarbose 25 MG Oral TabletPSN722ce9eb-8f7b-4651-a287-d53dd7ab370728
199149acarbose 50 MG Oral TabletPSN722ce9eb-8f7b-4651-a287-d53dd7ab370728
199150acarbose 100 MG Oral TabletSCD722ce9eb-8f7b-4651-a287-d53dd7ab370728
200132acarbose 25 MG Oral TabletSCD722ce9eb-8f7b-4651-a287-d53dd7ab370728
199149acarbose 50 MG Oral TabletSCD722ce9eb-8f7b-4651-a287-d53dd7ab370728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-133-307278901333030 TABLET in 1 BOTTLE, PLASTIC (72789-133-30) 30 tablet2023-07-07NoNoHistorical
72789-133-607278901336060 TABLET in 1 BOTTLE, PLASTIC (72789-133-60) 60 tablet2020-10-210000-00-00NoNoCurrent
72789-133-907278901339090 TABLET in 1 BOTTLE, PLASTIC (72789-133-90) 90 tablet2022-09-160000-00-00NoNoCurrent