Home NDC 10135-772 Acetazolamide
Product NDC 10135-772
11-digit product format 101350772
Labeler code 10135
Product ID 10135-772_efe4aced-f725-4cc0-e053-2a95a90ae650
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA210588
Marketing category ANDA
Marketing start 2022-12-01
Marketing end 0000-00-00
Substance ACETAZOLAMIDE
Active strength 125 mg/1
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210588-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 A210588-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 78 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 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210588-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210588-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-772-01 Acetazolamide 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-772 ACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS, INC.] 3 Legacy NDC, 1 package rows 20240915_efe4aced-f724-4cc0-e053-2a95a90ae650.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 · 1 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 10135-772-01 10135077201 100 TABLET in 1 BOTTLE (10135-772-01) 100 tablet 2022-12-01 0000-00-00 No No Current