Home NDC 72789-133 Acarbose
Product NDC 72789-133
11-digit product format 727890133
Labeler code 72789
Product ID 72789-133_2c2501a6-a6d6-1d6c-e063-6294a90ad428
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acarbose
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, 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 2027-12-31 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 72789-133-30 Acarbose 30 in 1 BOTTLE, PLASTIC TABLET 30 28 72789-133-60 Acarbose 60 in 1 BOTTLE, PLASTIC TABLET 60 28 72789-133-90 Acarbose 90 in 1 BOTTLE, PLASTIC TABLET 90 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-133 ACARBOSE TABLET [PD-RX PHARMACEUTICALS, INC.] 28 Current NDC, Legacy NDC, 3 package rows 20250121_722ce9eb-8f7b-4651-a287-d53dd7ab3707.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 72789-133-01 72789013301 100 TABLET in 1 BOTTLE, PLASTIC (72789-133-01) 100 tablet 2026-06-24 0 Current 72789-133-30 72789013330 30 TABLET in 1 BOTTLE, PLASTIC (72789-133-30) 30 tablet 2023-07-07 No No Current 72789-133-60 72789013360 60 TABLET in 1 BOTTLE, PLASTIC (72789-133-60) 60 tablet 2020-10-21 0000-00-00 No No Current 72789-133-90 72789013390 90 TABLET in 1 BOTTLE, PLASTIC (72789-133-90) 90 tablet 2022-09-16 0000-00-00 No No Current