Home NDC 50090-0577 Acetazolamide
Product NDC 50090-0577
11-digit product format 500900577
Labeler code 50090
Product ID 50090-0577_732bbff0-26a5-48ee-a949-8654a41ea730
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA040195
Marketing category ANDA
Marketing start 1997-05-28
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 2022-12-31
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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-0577-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-0577-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-0577-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-0577-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-0577-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-0577-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-0577-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-0577-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-0577-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-0577-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-0577-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-0577-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-0577-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-0577-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-0577-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50090-0577-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A040195-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 A040195-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28
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 3 · 82 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 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040195-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 1997-05-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040195-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB RS 1997-05-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0577 ACETAZOLAMIDE TABLET [A-S MEDICATION SOLUTIONS] 8 Legacy NDC 20210219_af305773-e070-46eb-95f4-07b32a64b29a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-0577-1 50090057701 12 TABLET in 1 BOTTLE (50090-0577-1) 12 tablet 2016-06-29 0000-00-00 No No Current