Home NDC 0615-1511 AcetaZOLAMIDE
Product NDC 0615-1511
11-digit product format 006151511
Labeler code 0615
Product ID 0615-1511_7a721f27-95ce-4e0b-9a93-8cc3d8f6e188
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AcetaZOLAMIDE
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA040195
Marketing category ANDA
Marketing start 1997-05-28
Marketing end 0000-00-00
Substance ACETAZOLAMIDE
Active strength 250 mg/1
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-1511-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-1511-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-1511-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-1511-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-1511-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-1511-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-1511-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-1511-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-1511-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-1511-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-1511-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-1511-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-1511-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-1511-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-1511-39 I Inactivated by FDA 110d247fa046…a55b01930146…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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.