Acarbose

Product NDC
23155-149
Requested package NDC
23155-149-05
11-digit product format
231550149
Labeler code
23155
Product ID
23155-149_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
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

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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 23155-149-05
ndc (product): 23155-149
ndc11 (package): 23155014905
AcarboseACARBOSEChartwell RX, LLCd1b627e1-d78d-47dd-93f5-2bf4998466ba2025-12-09Adverse reactionsExact identifier
application applno (ANDA): 202271
application number: ANDA202271

Additional Listing Data#

Finished product
Yes
Brand name base
Acarbose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACARBOSE100 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
23155-149-01Acarbose100 in 1 BOTTLETABLET10023
23155-149-05Acarbose500 in 1 BOTTLETABLET50023
23155-149-10Acarbose1000 in 1 BOTTLETABLET100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-149-01EA - Each23155-1495c7db12b-66f1-4b08-ade7-1475da8c14aa12012-07-24
23155-149-05EA - Each23155-149677f9a9e-8f6e-47e9-963b-59bf048e3d5012014-01-04
23155-149-10EA - Each23155-14962831bc2-d6cd-45e9-829e-7946bd4b8b0112014-01-04

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
23155-149ACARBOSE 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
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
23155-149-0523155014905500 TABLET in 1 BOTTLE (23155-149-05) 500 tablet2021-04-160000-00-00NoNoCurrent