Home NDC 71335-1583-2 ACARBOSE
Product NDC 71335-1583
Requested package NDC 71335-1583-2
11-digit product format 713351583
Labeler code 71335
Product ID 71335-1583_6abd4ad4-4989-4403-a971-35dac770b2f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACARBOSE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091343
Marketing category ANDA
Marketing start 2015-02-01
Marketing end 0000-00-00
Substance ACARBOSE
Active strength 50 mg/1
Pharmacologic classes alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-1583 71335-1583-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-1583 71335-1583-2 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip f5e01cc5f278…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091343-001 ACARBOSE ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 A091343-002 ACARBOSE ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 A091343-003 ACARBOSE ACARBOSE 100MG TABLET / ORAL AB 2013-10-17
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 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091343-002 ACARBOSE 50MG TABLET / ORAL AB 2013-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091343-003 ACARBOSE 100MG TABLET / ORAL AB 2013-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091343-001 ACARBOSE 25MG TABLET / ORAL AB 2013-10-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1583-1 ACARBOSE 30 in 1 BOTTLE TABLET 30 1 71335-1583-2 ACARBOSE 90 in 1 BOTTLE TABLET 90 1 71335-1583-3 ACARBOSE 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1583 ACARBOSE TABLET [BRYANT RANCH PREPACK] 1 Legacy NDC, 3 package rows 20200924_c52016f3-98a0-455a-a1c8-0405b44208d7.zip
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 71335-1583-2 71335158302 90 TABLET in 1 BOTTLE (71335-1583-2) 90 tablet 2020-04-27 0000-00-00 No No Current