Acarbose

Product NDC
64380-759
11-digit product format
643800759
Labeler code
64380
Product ID
64380-759_590cf6ae-d307-481a-9f94-2039fb2774c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acarbose
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACARBOSE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT58MSI464G

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
64380-759-06Acarbose100 in 1 BOTTLE, PLASTICTABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-759-06EA - Each64380-7590ac3ddec-a250-4f79-92bf-29396ad66a7c12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACARBOSEACTIVE INGREDIENTT58MSI464GACARBOSE TABLET [STRIDES ARCOLAB LIMITED]2
ACARBOSEACTIVE MOIETYT58MSI464GACARBOSE TABLET [STRIDES ARCOLAB LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACARBOSE TABLET [STRIDES ARCOLAB LIMITED]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACARBOSE TABLET [STRIDES ARCOLAB LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACARBOSE TABLET [STRIDES ARCOLAB LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACARBOSE TABLET [STRIDES ARCOLAB LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-759ACARBOSE TABLET [STRIDES PHARMA SCIENCE LIMITED]8Current NDC, Legacy NDC, 1 package rows20220728_656769ee-e292-4950-83df-a38e6b1a9d6e.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
199149acarbose 50 MG Oral TabletPSNd4741580-8b93-41e3-b85f-565cb45c7dab2
199149acarbose 50 MG Oral TabletSCDd4741580-8b93-41e3-b85f-565cb45c7dab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-759-0664380075906100 TABLET in 1 BOTTLE, PLASTIC (64380-759-06) 100 tablet2016-12-100000-00-00NoNoCurrent