Methimazole
- Product NDC
- 64380-213
- 11-digit product format
- 643800213
- Labeler code
- 64380
- Product ID
- 64380-213_e355c721-78d1-4a61-96db-77df6c5b41ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methimazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA040350
- Marketing category
- ANDA
- Marketing start
- 2022-03-14
- 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
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 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 |
|---|
| 64380-213-01 | Methimazole | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 64380-213-02 | Methimazole | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-213 | METHIMAZOLE TABLET [STRIDES PHARMA SCIENCE LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220423_0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f.zip |
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 |
|---|
| 64380-213-01 | 64380021301 | 100 TABLET in 1 BOTTLE (64380-213-01) | 100 tablet | 2022-03-14 | 0000-00-00 | No | No | Current |
| 64380-213-02 | 64380021302 | 500 TABLET in 1 BOTTLE (64380-213-02) | 500 tablet | 2024-02-28 | | No | No | Current |