Home NDC 0185-0205 Methimazole
Product NDC 0185-0205
11-digit product format 001850205
Labeler code 0185
Product ID 0185-0205_3b0906f3-98c9-496d-9c4f-7783d938c53d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methimazole
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA040411
Marketing category ANDA
Marketing start 2001-03-27
Marketing end 2022-10-27
Substance METHIMAZOLE
Active strength 5 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHIMAZOLE ACTIVE INGREDIENT 554Z48XN5E METHIMAZOLE TABLET [EON LABS, INC.] 16 METHIMAZOLE ACTIVE MOIETY 554Z48XN5E METHIMAZOLE TABLET [EON LABS, INC.] 16 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHIMAZOLE TABLET [EON LABS, INC.] 16 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHIMAZOLE TABLET [EON LABS, INC.] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHIMAZOLE TABLET [EON LABS, INC.] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHIMAZOLE TABLET [EON LABS, INC.] 16 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHIMAZOLE TABLET [EON LABS, INC.] 16 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHIMAZOLE TABLET [EON LABS, INC.] 16 METHIMAZOLE ACTIVE INGREDIENT 554Z48XN5E METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 METHIMAZOLE ACTIVE MOIETY 554Z48XN5E METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHIMAZOLE TABLET [AMERICAN HEALTH PACKAGING] 4 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0185-0205-01 00185020501 100 TABLET in 1 BOTTLE (0185-0205-01) 100 tablet 2001-03-27 2022-09-27 No No Current 0185-0205-10 00185020510 1000 TABLET in 1 BOTTLE (0185-0205-10) 1000 tablet 2001-03-27 2022-06-27 No No Current