Home NDC 0574-0791 methazolamide
Product NDC 0574-0791
11-digit product format 005740791
Labeler code 0574
Product ID 0574-0791_94b58ed4-5a45-4777-924c-7608156be1b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methazolamide
Dosage form TABLET
Route ORAL
Labeler Padagis US LLC
Application ANDA040062
Marketing category ANDA
Marketing start 2014-09-30
Marketing end 2027-09-30
Substance METHAZOLAMIDE
Active strength 50 mg/1
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 A040062-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 1994-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040062-002 METHAZOLAMIDE 50MG TABLET / ORAL AB RS 1994-01-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base methazolamide Active Ingredients# Ingredient, Strength table Ingredient Strength METHAZOLAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W733B0S9SD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197939 Internal RxNorm lookup 197940 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 0574-0791-01 methazolamide 100 in 1 BOTTLE, PLASTIC TABLET 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHAZOLAMIDE ACTIVE INGREDIENT W733B0S9SD METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2 METHAZOLAMIDE ACTIVE MOIETY W733B0S9SD METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHAZOLAMIDE TABLET [PADDOCK LABORATORIES, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0791 METHAZOLAMIDE TABLET [PADAGIS US LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240629_5e0795e1-d5c5-4b04-9bce-077bb8028023.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0574-0791-01 00574079101 100 TABLET in 1 BOTTLE, PLASTIC (0574-0791-01) 100 tablet 2014-09-30 2026-08-31 No No Current