Home NDC 55806-021-03 methazolamide
Product NDC 55806-021
Requested package NDC 55806-021-03
11-digit product format 558060021
Labeler code 55806
Product ID 55806-021_ed0bf5f2-521c-27fe-e053-2995a90ab13b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methazolamide
Dosage form TABLET
Route ORAL
Labeler Effcon Laboratories, Inc.
Application ANDA040062
Marketing category ANDA
Marketing start 1994-07-14
Marketing end 0000-00-00
Substance METHAZOLAMIDE
Active strength 25 mg/1
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHAZOLAMIDE ACTIVE INGREDIENT W733B0S9SD METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2 METHAZOLAMIDE ACTIVE MOIETY W733B0S9SD METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55806-021 METHAZOLAMIDE TABLET [EFFCON LABORATORIES, INC.] 6 Legacy NDC 20240110_8e162b6d-8fa6-45f6-80d8-5132d94c1207.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55806-021-03 55806002103 100 TABLET in 1 BOTTLE, PLASTIC (55806-021-03) 100 tablet 1994-07-14 0000-00-00 No No Current