Home NDC 50090-5617 acetazolamide
Product NDC 50090-5617
11-digit product format 500905617
Labeler code 50090
Product ID 50090-5617_120056fe-47c8-4cac-9450-0ed12e14b489
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetazolamide
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA205530
Marketing category ANDA
Marketing start 2016-10-27
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 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 A205530-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 A205530-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27
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 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205530-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2016-10-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205530-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2016-10-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 125 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197303 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5617-0 acetazolamide 100 in 1 BOTTLE TABLET 100 12 50090-5617-1 acetazolamide 12 in 1 BOTTLE TABLET 12 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5617 ACETAZOLAMIDE TABLET [A-S MEDICATION SOLUTIONS] 10 Current NDC, Legacy NDC, 2 package rows 20240606_07fd0bde-8f7c-47d2-9e81-2c1eee259fa6.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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join acetazolamide ACETAZOLAMIDE Major Pharmaceuticals 37135ba5-63fd-427f-9b4a-8b7d1009bbca 2026-05-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205530 application number: ANDA205530 acetazolamide ACETAZOLAMIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 0700a910-79aa-4431-aecf-637fe14fcae8 2026-05-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205530 application number: ANDA205530 acetazolamide ACETAZOLAMIDE A-S Medication Solutions 07fd0bde-8f7c-47d2-9e81-2c1eee259fa6 2026-05-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205530 application number: ANDA205530 ndc (product): 50090-5617 acetazolamide ACETAZOLAMIDE AvKARE d6fba129-ac6e-4d04-bd09-8470be4e7ecc 2026-02-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205530 application number: ANDA205530 acetazolamide ACETAZOLAMIDE Northwind Health Company, LLC f8232eaf-e108-aa00-e053-6394a90aede4 2026-01-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205530 application number: ANDA205530 Acetazolamide ACETAZOLAMIDE Chartwell RX, LLC f75bbf55-98ac-4f91-b6fd-17b5ac860e55 2024-10-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 205530 application number: ANDA205530
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 50090-5617-0 50090561700 100 TABLET in 1 BOTTLE (50090-5617-0) 100 tablet 2021-08-23 0000-00-00 No No Current 50090-5617-1 50090561701 12 TABLET in 1 BOTTLE (50090-5617-1) 12 tablet 2021-08-23 0000-00-00 No No Current