Home NDC 0615-6500 Methimazole
Product NDC 0615-6500
11-digit product format 006156500
Labeler code 0615
Product ID 0615-6500_e897d664-2a02-4d94-ab61-93252204ccd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methimazole
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA040411
Marketing category ANDA
Marketing start 2001-03-27
Marketing end 0000-00-00
Substance METHIMAZOLE
Active strength 5 mg/1
Pharmacologic classes Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-6500-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-6500-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-6500-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-6500-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-6500-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-6500-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-6500-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-6500-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-6500-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-6500-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-6500-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-6500-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-6500-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-6500-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-6500-39 I Inactivated by FDA 110d247fa046…a55b01930146…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHIMAZOLE ACTIVE INGREDIENT 554Z48XN5E METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 METHIMAZOLE ACTIVE MOIETY 554Z48XN5E METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHIMAZOLE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2
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.