Home NDC 55289-720 Acetazolamide
Product NDC 55289-720
11-digit product format 552890720
Labeler code 55289
Product ID 55289-720_3467aca9-10ce-20d3-e063-6394a90a6743
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA040195
Marketing category ANDA
Marketing start 1997-05-28
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 2026-12-31
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55289-720-06 Acetazolamide 6 in 1 BOTTLE, PLASTIC TABLET 6 17 55289-720-12 Acetazolamide 12 in 1 BOTTLE, PLASTIC TABLET 12 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetazolamide ACTIVE INGREDIENT O3FX965V0I ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Acetazolamide ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Gelatin INACTIVE INGREDIENT 2G86QN327L ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Talc INACTIVE INGREDIENT 7SEV7J4R1U ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-720 ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20250507_bd911de5-ea56-41ba-a328-20c8bfe7fe3b.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 55289-720-06 55289072006 6 TABLET in 1 BOTTLE, PLASTIC (55289-720-06) 6 tablet 2016-03-03 0000-00-00 No No Current 55289-720-12 55289072012 12 TABLET in 1 BOTTLE, PLASTIC (55289-720-12) 12 tablet 2016-03-03 0000-00-00 No No Current