Home NDC 27241-132 Acetazolamide
Product NDC 27241-132
11-digit product format 272410132
Labeler code 27241
Product ID 27241-132_ad9685e5-3506-499d-86a1-57df874a6c68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA211151
Marketing category ANDA
Marketing start 2023-09-11
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 44 .
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 A211151-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 A211151-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11
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 · 46 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 2026-10-15 13:18:30 2026-09 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL 2023-09-11 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL 2023-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-09-11 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211151-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2023-09-11 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A211151-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2023-09-11 ea1830bbd6c7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 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 27241-132-04 Acetazolamide 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-132 ACETAZOLAMIDE TABLET [AJANTA PHARMA USA INC.] 5 Current NDC, 1 package rows 20250418_240ab24b-3124-4805-80c2-36dd1945e3b3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27241-132-04 27241013204 100 TABLET in 1 BOTTLE (27241-132-04) 100 tablet 2023-09-11 No No Current