FDA.reportPublic FDA data

Acarbose

Product NDC
63629-5698
11-digit product format
636295698
Labeler code
63629
Product ID
63629-5698_8af70082-d192-4446-8afc-186dc6aa3efb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acarbose
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090912
Marketing category
ANDA
Marketing start
2016-12-10
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, 200132

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5698-12020-02-25C16284748780-19d75b9cf-dd21-f424-e053-dadaa90a57ceAcarbose Tablets
63629-5698-22020-02-25C16284748780-19d75b9cf-dd21-f424-e053-dadaa90a57ceAcarbose Tablets
63629-5698-32020-02-25C16284748780-19d75b9cf-dd21-f424-e053-dadaa90a57ceAcarbose Tablets
63629-5698-12020-01-31C16284748780-19d75b9cf-dd21-f424-e053-dadaa90a57ceAcarbose Tablets
63629-5698-22020-01-31C16284748780-19d75b9cf-dd21-f424-e053-dadaa90a57ceAcarbose Tablets
63629-5698-32020-01-31C16284748780-19d75b9cf-dd21-f424-e053-dadaa90a57ceAcarbose Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5698-1Acarbose30 in 1 BOTTLETABLET309
63629-5698-2Acarbose90 in 1 BOTTLETABLET909
63629-5698-3Acarbose100 in 1 BOTTLETABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5698ACARBOSE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 3 package rows20231123_1ba7a072-03b0-41f2-be7a-101145bdef3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200132acarbose 25 MG Oral TabletPSN1ba7a072-03b0-41f2-be7a-101145bdef3a9
199149acarbose 50 MG Oral TabletPSN1ba7a072-03b0-41f2-be7a-101145bdef3a9
200132acarbose 25 MG Oral TabletSCD1ba7a072-03b0-41f2-be7a-101145bdef3a9
199149acarbose 50 MG Oral TabletSCD1ba7a072-03b0-41f2-be7a-101145bdef3a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5698-16362956980130 TABLET in 1 BOTTLE (63629-5698-1) 30 tablet2016-12-100000-00-00NoNoCurrent
63629-5698-26362956980290 TABLET in 1 BOTTLE (63629-5698-2) 90 tablet2016-12-100000-00-00NoNoCurrent
63629-5698-363629569803100 TABLET in 1 BOTTLE (63629-5698-3) 100 tablet2016-12-100000-00-00NoNoCurrent