Acarbose

Product NDC
23155-148
Requested package NDC
23155-148-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202271-001ACARBOSEACARBOSE25MGTABLET / ORALAB2012-02-07
A202271-002ACARBOSEACARBOSE50MGTABLET / ORALAB2012-02-07
A202271-003ACARBOSEACARBOSE100MGTABLET / ORALAB2012-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202271-001AB
A202271-002AB
A202271-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202271-002ACARBOSE50MGTABLET / ORALAB2012-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202271-003ACARBOSE100MGTABLET / ORALAB2012-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202271-001ACARBOSE25MGTABLET / ORALAB2012-02-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202271-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202271-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202271-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202271-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202271-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202271-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202271-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202271-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202271-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202271-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202271-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202271-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202271-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202271-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202271-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202271-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202271-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202271-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202271-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202271-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202271-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202271-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202271-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202271-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202271-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202271-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202271-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202271-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202271-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202271-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202271-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202271-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202271-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202271-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202271-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202271-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202271-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202271-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202271-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202271-001AB18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T58MSI464GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199149Internal RxNorm lookup
199150Internal RxNorm lookup
200132Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
29939129-7d09-4c22-bf3e-491a8a97f4c4Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcarboseACARBOSEBryant Ranch Prepack067c0adc-7322-489d-9baa-1d061b37be362026-07-16Adverse reactionsExact identifier
application applno (ANDA): 202271
application number: ANDA202271
AcarboseACARBOSEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.29939129-7d09-4c22-bf3e-491a8a97f4c42026-06-18Adverse reactionsExact identifier
application applno (ANDA): 202271
application number: ANDA202271
ndc (package): 23155-148-01
ndc (product): 23155-148
ndc11 (package): 23155014801
AcarboseACARBOSEChartwell RX, LLCd1b627e1-d78d-47dd-93f5-2bf4998466ba2025-12-09Adverse reactionsExact identifier
application applno (ANDA): 202271
application number: ANDA202271

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