Acarbose

Product NDC
50090-5829
Requested package NDC
50090-5829-0
11-digit product format
500905829
Labeler code
50090
Product ID
50090-5829_49410201-806b-4f8b-9638-24f91d5ae72b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acarbose
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090912
Marketing category
ANDA
Marketing start
2016-12-10
Marketing end
0000-00-00
Substance
ACARBOSE
Active strength
100 mg/1
Pharmacologic classes
alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-582950090-5829-0IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A090912-001ACARBOSEACARBOSE25MGTABLET / ORALABRS2011-07-27
A090912-002ACARBOSEACARBOSE50MGTABLET / ORALAB2011-07-27
A090912-003ACARBOSEACARBOSE100MGTABLET / ORALAB2011-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090912-001AB
A090912-002AB
A090912-003AB

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 UTC2026-02A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090912-002ACARBOSE50MGTABLET / ORALAB2011-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090912-003ACARBOSE100MGTABLET / ORALAB2011-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090912-001ACARBOSE25MGTABLET / ORALABRS2011-07-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090912-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090912-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090912-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090912-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090912-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090912-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090912-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090912-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090912-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090912-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090912-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090912-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090912-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090912-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090912-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090912-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090912-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090912-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090912-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090912-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090912-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090912-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090912-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090912-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090912-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090912-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090912-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090912-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090912-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090912-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2712f130-8721-1a9d-6846-53893b13fb67Product name220210312

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5829-02023-01-30C16284748780-1f386c649-f940-0266-e053-dadaa90a7c1aAcarbose Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5829-0Acarbose30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5829-0EA - Each50090-58296b27d806-67e3-4123-af5c-d652ea4fa4aa12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5829ACARBOSE TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20211030_bf8500e1-9037-43f5-855b-d336d92d5cb7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcarboseACARBOSEStrides Pharma Science Limited656769ee-e292-4950-83df-a38e6b1a9d6e2026-07-15Adverse reactionsExact identifier
application applno (ANDA): 090912
application number: ANDA090912
AcarboseACARBOSEBryant Ranch Prepack1ba7a072-03b0-41f2-be7a-101145bdef3a2023-11-22Adverse reactionsExact identifier
application applno (ANDA): 090912
application number: ANDA090912

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199150acarbose 100 MG Oral TabletPSNbf8500e1-9037-43f5-855b-d336d92d5cb71
199150acarbose 100 MG Oral TabletSCDbf8500e1-9037-43f5-855b-d336d92d5cb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5829-05009058290030 TABLET in 1 BOTTLE (50090-5829-0) 30 tablet2021-10-260000-00-00NoNoCurrent