FDA.reportPublic FDA data

Acarbose

Product NDC
0054-0141
11-digit product format
000540141
Labeler code
0054
Product ID
0054-0141_2d7f6918-65c3-4db3-b775-b74e1e637cea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acarbose
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078470
Marketing category
ANDA
Marketing start
2008-05-07
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, 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
0054-0141-20Acarbose10 in 1 CARTONTABLET1011
0054-0141-20Acarbose10 in 1 BLISTER PACKTABLET1011
0054-0141-25Acarbose100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0141-20EA - Each0054-014137687a7f-0296-4fe1-bc5f-85b9dd0e723a12012-07-24
0054-0141-25EA - Each0054-01419374408e-4cb9-4a08-a15e-f8ab7e23674912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACARBOSEACTIVE INGREDIENTT58MSI464GACARBOSE TABLET [ROXANE LABORATORIES, INC]6
ACARBOSEACTIVE MOIETYT58MSI464GACARBOSE TABLET [ROXANE LABORATORIES, INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACARBOSE TABLET [ROXANE LABORATORIES, INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACARBOSE TABLET [ROXANE LABORATORIES, INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACARBOSE TABLET [ROXANE LABORATORIES, INC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACARBOSE TABLET [ROXANE LABORATORIES, INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0141ACARBOSE TABLET [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 3 package rows20240724_352dd336-d3f9-4ac5-a000-91d3aef7aca3.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
199150acarbose 100 MG Oral TabletPSN352dd336-d3f9-4ac5-a000-91d3aef7aca311
200132acarbose 25 MG Oral TabletPSN352dd336-d3f9-4ac5-a000-91d3aef7aca311
199149acarbose 50 MG Oral TabletPSN352dd336-d3f9-4ac5-a000-91d3aef7aca311
199150acarbose 100 MG Oral TabletSCD352dd336-d3f9-4ac5-a000-91d3aef7aca311
200132acarbose 25 MG Oral TabletSCD352dd336-d3f9-4ac5-a000-91d3aef7aca311
199149acarbose 50 MG Oral TabletSCD352dd336-d3f9-4ac5-a000-91d3aef7aca311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0141-200005401412010 BLISTER PACK in 1 CARTON (0054-0141-20) > 10 TABLET in 1 BLISTER PACK10 blister pack2008-05-070000-00-00NoNoCurrent
0054-0141-2500054014125100 TABLET in 1 BOTTLE (0054-0141-25) 100 tablet2008-05-070000-00-00NoNoCurrent