Acarbose

Product NDC
62135-455
11-digit product format
621350455
Labeler code
62135
Product ID
62135-455_458bb3c6-f92c-cf49-e063-6294a90a96c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acarbose
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA202271
Marketing category
ANDA
Marketing start
2021-04-16
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
62135-455-90Acarbose90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-455-90EA - Each62135-4558f5ab3f5-e56a-4776-a19e-8d35593ad9f012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-455ACARBOSE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241012_d1b627e1-d78d-47dd-93f5-2bf4998466ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199150acarbose 100 MG Oral TabletPSNd1b627e1-d78d-47dd-93f5-2bf4998466ba3
200132acarbose 25 MG Oral TabletPSNd1b627e1-d78d-47dd-93f5-2bf4998466ba3
199149acarbose 50 MG Oral TabletPSNd1b627e1-d78d-47dd-93f5-2bf4998466ba3
199150acarbose 100 MG Oral TabletSCDd1b627e1-d78d-47dd-93f5-2bf4998466ba3
200132acarbose 25 MG Oral TabletSCDd1b627e1-d78d-47dd-93f5-2bf4998466ba3
199149acarbose 50 MG Oral TabletSCDd1b627e1-d78d-47dd-93f5-2bf4998466ba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-455-906213504559090 TABLET in 1 BOTTLE (62135-455-90) 90 tablet2023-01-31NoNoCurrent