FDA.reportPublic FDA data

Acarbose

Product NDC
23155-148
11-digit product format
231550148
Labeler code
23155
Product ID
23155-148_54493f37-e851-40e4-83e0-6f16eddc8b04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acarbose
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202271
Marketing category
ANDA
Marketing start
2021-04-16
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
23155-148-01Acarbose100 in 1 BOTTLETABLET10023
23155-148-05Acarbose500 in 1 BOTTLETABLET50023
23155-148-10Acarbose1000 in 1 BOTTLETABLET100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-148-01EA - Each23155-1486172c2aa-bb0e-4e0f-ab1f-74c0316d428b12012-07-24
23155-148-05EA - Each23155-1486fe1226d-9642-48dd-aedc-04be4fb81d9312014-01-04
23155-148-10EA - Each23155-1485f8434a4-0b02-41c7-95eb-4b1ba73a8a3412014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACARBOSEACTIVE INGREDIENTT58MSI464GACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC.]12
ACARBOSEACTIVE MOIETYT58MSI464GACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-148ACARBOSE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]23Current NDC, Legacy NDC, 3 package rows20240705_29939129-7d09-4c22-bf3e-491a8a97f4c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199149acarbose 50 MG Oral TabletPSN067c0adc-7322-489d-9baa-1d061b37be36101
199149acarbose 50 MG Oral TabletSCD067c0adc-7322-489d-9baa-1d061b37be36101
199150acarbose 100 MG Oral TabletPSN29939129-7d09-4c22-bf3e-491a8a97f4c423
200132acarbose 25 MG Oral TabletPSN29939129-7d09-4c22-bf3e-491a8a97f4c423
199149acarbose 50 MG Oral TabletPSN29939129-7d09-4c22-bf3e-491a8a97f4c423
199150acarbose 100 MG Oral TabletSCD29939129-7d09-4c22-bf3e-491a8a97f4c423
200132acarbose 25 MG Oral TabletSCD29939129-7d09-4c22-bf3e-491a8a97f4c423
199149acarbose 50 MG Oral TabletSCD29939129-7d09-4c22-bf3e-491a8a97f4c423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-148-0123155014801100 TABLET in 1 BOTTLE (23155-148-01) 100 tablet2021-04-160000-00-00NoNoCurrent
23155-148-0523155014805500 TABLET in 1 BOTTLE (23155-148-05) 500 tablet2021-04-160000-00-00NoNoCurrent
23155-148-10231550148101000 TABLET in 1 BOTTLE (23155-148-10) 1000 tablet2021-04-160000-00-00NoNoCurrent