Home NDC 46672-109 Methazolamide
Product NDC 46672-109
11-digit product format 466720109
Labeler code 46672
Product ID 46672-109_afe833c9-2227-9b73-e053-2995a90a1947
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methazolamide
Dosage form TABLET
Route ORAL
Labeler Mikart, LLC
Application ANDA040062
Marketing category ANDA
Marketing start 1994-01-28
Marketing end 0000-00-00
Substance METHAZOLAMIDE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 A040062-001 METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 A040062-002 METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27
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 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46672-109-09 46672010909 90 TABLET in 1 BOTTLE, PLASTIC (46672-109-09) 90 tablet 2020-06-01 0000-00-00 No No Current 46672-109-10 46672010910 100 TABLET in 1 BOTTLE, PLASTIC (46672-109-10) 100 tablet 2020-06-01 0000-00-00 No No Current