Home NDC 70756-721-99 Acetazolamide
Product NDC 70756-721
Requested package NDC 70756-721-99
11-digit product format 707560721
Labeler code 70756
Product ID 70756-721_4591855f-1da8-4477-8ec0-ae41f0ac3db6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler Lifestar Pharma LLC
Application ANDA214282
Marketing category ANDA
Marketing start 2020-11-13
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A214282-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 A214282-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07
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 2026-11-14 07:37:17 2026-10 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214282-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2020-10-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214282-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2020-10-07 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 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 70756-721-11 Acetazolamide 100 in 1 BOTTLE TABLET 100 11 70756-721-99 Acetazolamide 10 in 1 CARTON TABLET 10 11 70756-721-99 Acetazolamide 10 in 1 BLISTER PACK TABLET 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70756-721 ACETAZOLAMIDE TABLET [LIFESTAR PHARMA LLC] 9 Current NDC, Legacy NDC, 3 package rows 20241020_0913db35-3f08-4d82-8394-486bd9a487c4.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70756-721-99 70756072199 10 BLISTER PACK in 1 CARTON (70756-721-99) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2024-05-15 No No Current