Home NDC 51672-4022 Acetazolamide
Product NDC 51672-4022
11-digit product format 516724022
Labeler code 51672
Product ID 51672-4022_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 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 51672-4022-1 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 [PD-RX PHARMACEUTICALS, INC.] 2 Acetazolamide ACTIVE INGREDIENT O3FX965V0I ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Acetazolamide ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Acetazolamide ACTIVE MOIETY O3FX965V0I ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Gelatin INACTIVE INGREDIENT 2G86QN327L ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, 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 Glycerin INACTIVE INGREDIENT PDC6A3C0OX ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, 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 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 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, 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 Talc INACTIVE INGREDIENT 7SEV7J4R1U ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R ACETAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4022 ACETAZOLAMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20250406_abeb13eb-66a5-4030-9bc2-5981acd196b9.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 51672-4022-1 51672402201 100 TABLET in 1 BOTTLE (51672-4022-1) 100 tablet 1997-05-28 0000-00-00 No No Current