Home NDC 0054-0142 Acarbose
Product NDC 0054-0142
11-digit product format 000540142
Labeler code 0054
Product ID 0054-0142_2d7f6918-65c3-4db3-b775-b74e1e637cea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acarbose
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA078470
Marketing category ANDA
Marketing start 2008-05-07
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078470-001 ACARBOSE ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 A078470-002 ACARBOSE ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 A078470-003 ACARBOSE ACARBOSE 100MG TABLET / ORAL AB 2008-05-07
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 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078470-002 ACARBOSE 50MG TABLET / ORAL AB 2008-05-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078470-003 ACARBOSE 100MG TABLET / ORAL AB 2008-05-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078470-001 ACARBOSE 25MG TABLET / ORAL AB 2008-05-07 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACARBOSE 100 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 0054-0142-25 Acarbose 100 in 1 BOTTLE TABLET 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACARBOSE ACTIVE INGREDIENT T58MSI464G ACARBOSE TABLET [ROXANE LABORATORIES, INC] 6 ACARBOSE ACTIVE MOIETY T58MSI464G ACARBOSE TABLET [ROXANE LABORATORIES, INC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACARBOSE TABLET [ROXANE LABORATORIES, INC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACARBOSE TABLET [ROXANE LABORATORIES, INC] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACARBOSE TABLET [ROXANE LABORATORIES, INC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACARBOSE TABLET [ROXANE LABORATORIES, INC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0142 ACARBOSE TABLET [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 1 package rows 20240724_352dd336-d3f9-4ac5-a000-91d3aef7aca3.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 0054-0142-25 00054014225 100 TABLET in 1 BOTTLE (0054-0142-25) 100 tablet 2008-05-07 0000-00-00 No No Current