Home NDC 64380-758 Acarbose
Product NDC 64380-758
11-digit product format 643800758
Labeler code 64380
Product ID 64380-758_590cf6ae-d307-481a-9f94-2039fb2774c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acarbose
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA090912
Marketing category ANDA
Marketing start 2016-12-08
Substance ACARBOSE
Active strength 25 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090912-001 ACARBOSE ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 A090912-002 ACARBOSE ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 A090912-003 ACARBOSE ACARBOSE 100MG TABLET / ORAL AB 2011-07-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090912-002 ACARBOSE 50MG TABLET / ORAL AB 2011-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090912-003 ACARBOSE 100MG TABLET / ORAL AB 2011-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090912-001 ACARBOSE 25MG TABLET / ORAL AB RS 2011-07-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acarbose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACARBOSE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T58MSI464G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199149 Internal RxNorm lookup 199150 Internal RxNorm lookup 200132 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-758-06 Acarbose 100 in 1 BOTTLE, PLASTIC TABLET 100 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-758 ACARBOSE TABLET [STRIDES PHARMA SCIENCE LIMITED] 8 Current NDC, Legacy NDC, 1 package rows 20220728_656769ee-e292-4950-83df-a38e6b1a9d6e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-758-06 64380075806 100 TABLET in 1 BOTTLE, PLASTIC (64380-758-06) 100 tablet 2016-12-08 0000-00-00 No No Current