Home NDC 42571-240 METHAZOLAMIDE
Product NDC 42571-240
11-digit product format 425710240
Labeler code 42571
Product ID 42571-240_9ebf7533-27e6-54c2-e053-2995a90ae560
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methazolamide
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA207438
Marketing category ANDA
Marketing start 2019-03-05
Substance METHAZOLAMIDE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A207438-001 METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 A207438-002 METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05
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 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL 2018-10-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL 2018-10-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207438-001 METHAZOLAMIDE 25MG TABLET / ORAL AB 2018-10-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207438-002 METHAZOLAMIDE 50MG TABLET / ORAL AB 2018-10-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base METHAZOLAMIDE
Listing expiration 2026-12-31 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 42571-240-05 METHAZOLAMIDE 500 in 1 BOTTLE TABLET 500 5 42571-240-10 METHAZOLAMIDE 1000 in 1 BOTTLE TABLET 1000 5 42571-240-90 METHAZOLAMIDE 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-240 METHAZOLAMIDE (METHAZOLAMIDE) TABLET [MICRO LABS LIMITED] 5 Current NDC, Legacy NDC, 3 package rows 20200217_91a493f5-f8c3-4b64-a15e-b550d8631668.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.
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 42571-240-05 42571024005 500 TABLET in 1 BOTTLE (42571-240-05) 500 tablet 2019-03-05 0000-00-00 No No Current 42571-240-10 42571024010 1000 TABLET in 1 BOTTLE (42571-240-10) 1000 tablet 2019-03-05 0000-00-00 No No Current 42571-240-90 42571024090 90 TABLET in 1 BOTTLE (42571-240-90) 90 tablet 2019-03-05 0000-00-00 No No Current