Home NDC 62135-454 Acarbose
Product NDC 62135-454
11-digit product format 621350454
Labeler code 62135
Product ID 62135-454_458bb3c6-f92c-cf49-e063-6294a90a96c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acarbose
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA202271
Marketing category ANDA
Marketing start 2021-04-16
Substance ACARBOSE
Active strength 50 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 A202271-001 ACARBOSE ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 A202271-002 ACARBOSE ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 A202271-003 ACARBOSE ACARBOSE 100MG TABLET / ORAL AB 2012-02-07
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 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202271-002 ACARBOSE 50MG TABLET / ORAL AB 2012-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202271-003 ACARBOSE 100MG TABLET / ORAL AB 2012-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202271-001 ACARBOSE 25MG TABLET / ORAL AB 2012-02-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 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 50 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 62135-454-90 Acarbose 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-454 ACARBOSE TABLET [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241012_d1b627e1-d78d-47dd-93f5-2bf4998466ba.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-454-90 62135045490 90 TABLET in 1 BOTTLE (62135-454-90) 90 tablet 2023-01-31 No No Current