methimazole
- Product NDC
- 76483-083
- 11-digit product format
- 764830083
- Labeler code
- 76483
- Product ID
- 76483-083_3b305195-ceb2-495c-82c0-fa90bd5c1780
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methimazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SQUARE PHARMACEUTICALS PLC.
- Application
- ANDA218830
- Marketing category
- ANDA
- Marketing start
- 2024-12-31
- 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 |
|---|
| 76483-083-00 | methimazole | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76483-083 | METHIMAZOLE TABLET [SQUARE PHARMACEUTICALS PLC.] | 2 | Current NDC, 1 package rows | 20250214_33e065a1-dd4e-43f9-a841-f96e633fc850.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 |
|---|
| 76483-083-00 | 76483008300 | 100 TABLET in 1 BOTTLE (76483-083-00) | 100 tablet | 2024-12-31 | No | No | Current |