Methimazole
- Product NDC
- 68788-8883
- 11-digit product format
- 687888883
- Labeler code
- 68788
- Product ID
- 68788-8883_c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methimazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202068
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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 | 197942 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8883-1 | Methimazole | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 68788-8883-3 | Methimazole | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8883-1 | 68788888301 | 100 TABLET in 1 BOTTLE (68788-8883-1) | 100 tablet | 2025-06-02 | No | No | Historical |
| 68788-8883-3 | 68788888303 | 30 TABLET in 1 BOTTLE (68788-8883-3) | 30 tablet | 2025-06-02 | No | No | Historical |