Home NDC 68071-3550 Acetazolamide
Product NDC 68071-3550
11-digit product format 680713550
Labeler code 68071
Product ID 68071-3550_2d3fc60b-5a3e-6abc-e063-6394a90af2a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA215101
Marketing category ANDA
Marketing start 2021-08-19
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3550-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3550-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3550-1 0efc9e666f02…f202fb6c5f17…
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 A215101-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 A215101-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19
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 2 · 66 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 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215101-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2021-08-19 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215101-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2021-08-19 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acetazolamide
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197303 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3550-1 Acetazolamide 12 in 1 BOTTLE TABLET 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3550 ACETAZOLAMIDE TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 1 package rows 20250205_0b76c194-b244-e9ac-e063-6394a90a373e.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 · 3 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 68071-3550-1 68071355001 12 TABLET in 1 BOTTLE (68071-3550-1) 12 tablet 2023-12-01 No No Current