Home NDC 62135-206 Methimazole
Product NDC 62135-206
11-digit product format 621350206
Labeler code 62135
Product ID 62135-206_4cb57dfc-1ebf-8510-e063-6294a90a31fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methimazole
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA040411
Marketing category ANDA
Marketing start 2001-03-27
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 2027-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Methimazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHIMAZOLE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 554Z48XN5E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197941 Internal RxNorm lookup 197942 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 62135-206-01 Methimazole 100 in 1 BOTTLE TABLET 100 4 62135-206-18 Methimazole 180 in 1 BOTTLE TABLET 180 4 62135-206-30 Methimazole 30 in 1 BOTTLE TABLET 30 4 62135-206-90 Methimazole 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-206 METHIMAZOLE TABLET [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20221213_5b25e346-11b6-44ed-89f9-ab927232ac19.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.
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 62135-206-01 62135020601 100 TABLET in 1 BOTTLE (62135-206-01) 100 tablet 2021-11-04 0000-00-00 No No Current 62135-206-18 62135020618 180 TABLET in 1 BOTTLE (62135-206-18) 180 tablet 2021-11-04 0000-00-00 No No Current 62135-206-30 62135020630 30 TABLET in 1 BOTTLE (62135-206-30) 30 tablet 2021-11-04 0000-00-00 No No Current 62135-206-90 62135020690 90 TABLET in 1 BOTTLE (62135-206-90) 90 tablet 2021-11-04 0000-00-00 No No Current