Home NDC 10135-831 Acetazolamide
Product NDC 10135-831
11-digit product format 101350831
Labeler code 10135
Product ID 10135-831_4a03f386-e570-d4cb-e063-6394a90a8228
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA217197
Marketing category ANDA
Marketing start 2026-02-01
Substance ACETAZOLAMIDE
Active strength 250 mg/1
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217197-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 A217197-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09
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 · 44 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 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217197-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-05-09 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217197-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-05-09 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acetazolamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAZOLAMIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O3FX965V0I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197303 Internal RxNorm lookup 197304 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 10135-831-01 Acetazolamide 100 in 1 BOTTLE TABLET 100 1
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 Sample Exclude flag Status 10135-831-01 10135083101 100 TABLET in 1 BOTTLE (10135-831-01) 100 tablet 2026-02-01 No No Current