Home NDC 51672-4023 Acetazolamide
Product NDC 51672-4023
11-digit product format 516724023
Labeler code 51672
Product ID 51672-4023_31e42345-2444-92e6-e063-6394a90ae741
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA040195
Marketing category ANDA
Marketing start 1997-05-28
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 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 51672-4023-1 Acetazolamide 100 in 1 BOTTLE TABLET 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetazolamide ACTIVE INGREDIENT O3FX965V0I ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Acetazolamide ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Gelatin INACTIVE INGREDIENT 2G86QN327L ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Glycerin INACTIVE INGREDIENT PDC6A3C0OX ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Talc INACTIVE INGREDIENT 7SEV7J4R1U ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Water INACTIVE INGREDIENT 059QF0KO0R ACETAZOLAMIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 4 Acetazolamide ACTIVE INGREDIENT O3FX965V0I ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Acetazolamide ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Gelatin INACTIVE INGREDIENT 2G86QN327L ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Talc INACTIVE INGREDIENT 7SEV7J4R1U ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 ACETAZOLAMIDE ACTIVE INGREDIENT O3FX965V0I ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 ACETAZOLAMIDE ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ACETAZOLAMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4023 ACETAZOLAMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20250406_abeb13eb-66a5-4030-9bc2-5981acd196b9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4023-1 51672402301 100 TABLET in 1 BOTTLE (51672-4023-1) 100 tablet 1997-05-28 0000-00-00 No No Current