Home NDC 69452-329 Methimazole
Product NDC 69452-329
11-digit product format 694520329
Labeler code 69452
Product ID 69452-329_141a7912-5f63-fe50-e063-6294a90a99ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methimazole
Dosage form TABLET
Route ORAL
Labeler Bionpharma Inc.
Application ANDA218149
Marketing category ANDA
Marketing start 2024-03-25
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 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 A218149-001 METHIMAZOLE METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 A218149-002 METHIMAZOLE METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25
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.
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 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218149-001 METHIMAZOLE 5MG TABLET / ORAL AB 2023-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218149-002 METHIMAZOLE 10MG TABLET / ORAL AB 2023-09-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methimazole
Listing expiration 2026-12-31 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 69452-329-20 Methimazole 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-329 METHIMAZOLE TABLET [BIONPHARMA INC.] 1 Current NDC, 1 package rows 20240325_141a91d5-b56e-06d6-e063-6394a90a11ba.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 · 2 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 69452-329-20 69452032920 100 TABLET in 1 BOTTLE (69452-329-20) 100 tablet 2024-03-25 No No Current