Methimazole
- Product NDC
- 33342-335
- 11-digit product format
- 333420335
- Labeler code
- 33342
- Product ID
- 33342-335_ea518c56-49d7-4770-8ded-21e443e71c3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methimazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA209827
- Marketing category
- ANDA
- Marketing start
- 2023-05-24
- 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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 554Z48XN5E |
| Rxcui | 197941, 197942 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-335-11 | Methimazole | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 33342-335-12 | Methimazole | 10 in 1 CARTON | TABLET | 10 | | 3 |
| 33342-335-12 | Methimazole | 10 in 1 BLISTER PACK | TABLET | 10 | | 3 |
| 33342-335-44 | Methimazole | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-335 | METHIMAZOLE TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 2 | Current NDC, 4 package rows | 20230910_6f08df05-cc29-45ef-8f6e-12272bfbb0d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-335-11 | 33342033511 | 100 TABLET in 1 BOTTLE (33342-335-11) | 100 tablet | 2023-05-24 | No | No | Current |
| 33342-335-12 | 33342033512 | 10 BLISTER PACK in 1 CARTON (33342-335-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2023-05-24 | No | No | Current |
| 33342-335-44 | 33342033544 | 1000 TABLET in 1 BOTTLE (33342-335-44) | 1000 tablet | 2023-05-24 | No | No | Current |