ACARBOSE

Product NDC
71205-856
Requested package NDC
71205-856-11
11-digit product format
712050856
Labeler code
71205
Product ID
71205-856_203cd13e-8c8d-4782-9e5a-2f9d1b20dd42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACARBOSE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091343
Marketing category
ANDA
Marketing start
2015-02-01
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
2023-12-31
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 packagepackage71205-85671205-856-11DDiscontinued by firm2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-85671205-856-11DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-85671205-856-11DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A091343-001ACARBOSEACARBOSE25MGTABLET / ORALAB2013-10-17
A091343-002ACARBOSEACARBOSE50MGTABLET / ORALAB2013-10-17
A091343-003ACARBOSEACARBOSE100MGTABLET / ORALAB2013-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091343-001AB
A091343-002AB
A091343-003AB

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 UTC2026-02A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091343-002ACARBOSE50MGTABLET / ORALAB2013-10-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091343-003ACARBOSE100MGTABLET / ORALAB2013-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091343-001ACARBOSE25MGTABLET / ORALAB2013-10-178072bd15b7f6…

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 UTC2026-02A091343-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091343-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091343-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091343-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091343-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091343-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091343-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091343-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091343-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091343-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091343-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091343-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091343-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091343-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091343-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091343-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091343-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091343-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091343-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091343-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091343-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091343-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091343-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091343-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091343-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091343-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091343-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091343-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091343-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091343-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091343-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091343-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091343-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091343-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091343-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091343-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091343-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091343-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091343-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091343-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-856-00EA - Each71205-8560087f04e-488e-44ac-907c-e7ea38177e8f12022-07-06
71205-856-11EA - Each71205-8562b122ec6-edb3-45f8-baf8-631a7c3e031112022-07-06
71205-856-30EA - Each71205-856b3db22b7-1817-4f0f-bd4b-6944ee42238312022-07-06
71205-856-55EA - Each71205-856cf51073b-08a6-4259-a4c1-0d633c26a54012022-07-06
71205-856-60EA - Each71205-85614d34764-9a83-46e2-8157-54dc3793c86212022-07-06
71205-856-72EA - Each71205-8561af8fa9e-038f-4415-ab11-d438a795500c12022-07-06
71205-856-78EA - Each71205-856319fd199-b18c-4e3f-82ae-2dabc444da4d12022-07-06
71205-856-90EA - Each71205-856b9d887b7-7e54-4a49-b6d3-16020fec244312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-856ACARBOSE TABLET [PROFICIENT RX LP]3Legacy NDC20241129_203cd13e-8c8d-4782-9e5a-2f9d1b20dd42.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-856-11712050856111000 TABLET in 1 BOTTLE (71205-856-11) 1000 tablet2022-05-250000-00-00NoNoCurrent