Home NDC 68788-8883 Methimazole
Product NDC 68788-8883
11-digit product format 687888883
Labeler code 68788
Product ID 68788-8883_c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methimazole
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA202068
Marketing category ANDA
Marketing start 2025-06-02
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 2026-12-31
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 A202068-001 METHIMAZOLE METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 A202068-002 METHIMAZOLE METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07
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 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202068-001 METHIMAZOLE 5MG TABLET / ORAL AB 2012-03-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202068-002 METHIMAZOLE 10MG TABLET / ORAL AB 2012-03-07 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHIMAZOLE 5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68788-8883-1 Methimazole 100 in 1 BOTTLE TABLET 100 1 68788-8883-3 Methimazole 30 in 1 BOTTLE TABLET 30 1
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8883-1 68788888301 100 TABLET in 1 BOTTLE (68788-8883-1) 100 tablet 2025-06-02 No No Current 68788-8883-3 68788888303 30 TABLET in 1 BOTTLE (68788-8883-3) 30 tablet 2025-06-02 No No Current