Home NDC 60687-619 Acetazolamide
Product NDC 60687-619
11-digit product format 606870619
Labeler code 60687
Product ID 60687-619_eb8eeba2-1d63-7069-e053-2a95a90a12d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetazolamide
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA211556
Marketing category ANDA
Marketing start 2022-04-25
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 No
Listing certified through 2023-12-31
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 · 4 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60687-619-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60687-619-01 f5e01cc5f278…a2eaf40c39c3…
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 A211556-001 ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 A211556-002 ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18
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 · 78 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 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL BX 2019-10-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL BX 2019-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211556-001 ACETAZOLAMIDE 125MG TABLET / ORAL AB 2019-10-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211556-002 ACETAZOLAMIDE 250MG TABLET / ORAL AB 2019-10-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-619 ACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING] 7 Legacy NDC 20241220_f8633f67-89e0-4a59-aa00-1d4cec306ff8.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-619-01 60687061901 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-619-01) > 1 TABLET in 1 BLISTER PACK (60687-619-11) 100 blister pack 2021-10-01 0000-00-00 No No Current