Methimazole
- Product NDC
- 23155-071
- 11-digit product format
- 231550071
- Labeler code
- 23155
- Product ID
- 23155-071_649d3946-dc8c-4319-814f-a991d417d380
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methimazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA040734
- Marketing category
- ANDA
- Marketing start
- 2012-01-15
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040734-001 | METHIMAZOLE | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | |
| A040734-002 | METHIMAZOLE | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040734-001 | AB |
| A040734-002 | AB |
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 | 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 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040734-001 | METHIMAZOLE | 5MG | TABLET / ORAL | AB | 2007-12-14 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040734-002 | METHIMAZOLE | 10MG | TABLET / ORAL | AB | 2007-12-14 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040734-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040734-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040734-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040734-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040734-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040734-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040734-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040734-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040734-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040734-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040734-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040734-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040734-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040734-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040734-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040734-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040734-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040734-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040734-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040734-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040734-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040734-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040734-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040734-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040734-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040734-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040734-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040734-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040734-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040734-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040734-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040734-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040734-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040734-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040734-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040734-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040734-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040734-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040734-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040734-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methimazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHIMAZOLE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 554Z48XN5E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8c3a9aaa-cdde-404b-9af6-5a88ef649aac | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 42f09d00-d445-e29e-bea8-dfb46b9366fc | Product name | 4 | 20251118 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23155-071-01 | Methimazole | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 23155-071-10 | Methimazole | 1000 in 1 BOTTLE | TABLET | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23155-071-01 | EA - Each | 23155-071 | bbaf55f9-960a-44c2-b37f-37f23af9c10e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methimazole | METHIMAZOLE | REMEDYREPACK INC. | b53f84ac-4263-478c-883d-aca7ab44fef5 | 2026-07-07 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | REMEDYREPACK INC. | 2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b | 2026-07-06 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Preferred Pharmaceuticals Inc. | c1e6f1ee-238c-466e-b223-3c3f63dac9ed | 2026-06-23 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Preferred Pharmaceuticals Inc. | 244d76f1-98e6-4305-8768-b104f6a4be07 | 2026-06-23 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Proficient Rx LP | e921f23b-a9bf-4313-9cfa-f0b29c06f72a | 2025-07-01 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Golden State Medical Supply, Inc. | 4eff3321-2fce-4bab-94af-7b16e333beed | 2024-09-24 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | NORTHSTAR RX LLC | 923fec30-90fd-4bd5-beb3-f2ca4fc171ee | 2024-06-28 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 381052c4-891c-4ae4-b63e-65229126cbca | 2023-11-10 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Bryant Ranch Prepack | 3ca961ca-cbf2-4a73-8c81-4205e01b2695 | 2023-11-08 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | A-S Medication Solutions | 87eb663e-5dd3-4a7a-8b28-7e19c5ad1173 | 2023-06-29 | Warnings, Adverse reactions | 040734 ANDA040734 |
| Methimazole | METHIMAZOLE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 8c3a9aaa-cdde-404b-9af6-5a88ef649aac | 2022-03-24 | Warnings, Adverse reactions | 040734 ANDA040734 23155-071 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 23155-071-01 | 23155007101 | 100 TABLET in 1 BOTTLE (23155-071-01) | 100 tablet | 2012-01-15 | 0000-00-00 | No | No | Current |
| 23155-071-10 | 23155007110 | 1000 TABLET in 1 BOTTLE (23155-071-10) | 1000 tablet | 2012-01-15 | 0000-00-00 | No | No | Current |