Methimazole
- Product NDC
- 50268-495
- 11-digit product format
- 502680495
- Labeler code
- 50268
- Product ID
- 50268-495_41168239-a16a-40e0-e063-6294a90a5c58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methimazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA218149
- Marketing category
- ANDA
- Marketing start
- 2025-10-13
- 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 |
|---|
| 50268-495-11 | Methimazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 50268-495-15 | Methimazole | 50 in 1 BOX | TABLET | 50 | | 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 |
|---|
| 50268-495-11 | 50268049511 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-495-15 | 50268049515 | 50 BLISTER PACK in 1 BOX (50268-495-15) / 1 TABLET in 1 BLISTER PACK (50268-495-11) | 50 blister pack | 2025-10-13 | No | No | Current |