Home NDC 52817-201 ACETAZOLAMIDE
Product NDC 52817-201
11-digit product format 528170201
Labeler code 52817
Product ID 52817-201_1df8bd81-54fe-44ea-98aa-5f13592dd8bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACETAZOLAMIDE
Dosage form TABLET
Route ORAL
Labeler TRUPHARMA, LLC
Application ANDA211372
Marketing category ANDA
Marketing start 2021-04-19
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A211372-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 A211372-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22
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 · 70 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 2026-08-18 06:07:40 2026-07 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211372-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-02-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211372-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-02-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ACETAZOLAMIDE
Listing expiration 2026-12-31 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 52817-201-00 ACETAZOLAMIDE 1000 in 1 BOTTLE, PLASTIC TABLET 1000 6 52817-201-10 ACETAZOLAMIDE 100 in 1 BOTTLE, PLASTIC TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-201 ACETAZOLAMIDE TABLET [TRUPHARMA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20220717_4fcd428a-7bf3-4e75-a834-1bdf1078107f.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 52817-201-00 52817020100 1000 TABLET in 1 BOTTLE, PLASTIC (52817-201-00) 1000 tablet 2021-06-01 0000-00-00 No No Current 52817-201-10 52817020110 100 TABLET in 1 BOTTLE, PLASTIC (52817-201-10) 100 tablet 2021-06-01 0000-00-00 No No Current