Home NDC 68084-276 Methimazole
Product NDC 68084-276
11-digit product format 680840276
Labeler code 68084
Product ID 68084-276_7df2cbb0-3f2d-6ca0-e053-2991aa0a4cfd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methimazole
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA040411
Marketing category ANDA
Marketing start 2010-03-03
Marketing end 2020-03-31
Substance METHIMAZOLE
Active strength 10 mg/1
Pharmacologic classes Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 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 68084-276-01 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 68084-276-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68084-276-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68084-276-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68084-276-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68084-276-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68084-276-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68084-276-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68084-276-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68084-276-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68084-276-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68084-276-01 557ba5c1ecfa…9c80585c8c6e…
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 A040411-001 METHIMAZOLE METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 A040411-002 METHIMAZOLE METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27
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 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040411-001 METHIMAZOLE 5MG TABLET / ORAL AB 2001-03-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040411-002 METHIMAZOLE 10MG TABLET / ORAL AB 2001-03-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# 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.