Propylthiouracil
- Product NDC
- 33342-314
- 11-digit product format
- 333420314
- Labeler code
- 33342
- Product ID
- 33342-314_7e848dc9-0f07-4dd1-8aa6-a64558a1ddb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propylthiouracil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA208867
- Marketing category
- ANDA
- Marketing start
- 2023-05-10
- Substance
- PROPYLTHIOURACIL
- Active strength
- 50 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
- Propylthiouracil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPYLTHIOURACIL | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 721M9407IY |
| Rxcui | 198175 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-314-11 | Propylthiouracil | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 33342-314-12 | Propylthiouracil | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 33342-314-12 | Propylthiouracil | 10 in 1 CARTON | TABLET | 10 | | 2 |
| 33342-314-44 | Propylthiouracil | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-314 | PROPYLTHIOURACIL TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 2 | Current NDC, 4 package rows | 20240922_a251e4cb-01f1-4fd8-bd30-362126b85073.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 |
|---|
| 33342-314-11 | 33342031411 | 100 TABLET in 1 BOTTLE (33342-314-11) | 100 tablet | 2023-05-10 | No | No | Historical |
| 33342-314-12 | 33342031412 | 10 BLISTER PACK in 1 CARTON (33342-314-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2023-05-10 | No | No | Historical |
| 33342-314-44 | 33342031444 | 1000 TABLET in 1 BOTTLE (33342-314-44) | 1000 tablet | 2023-05-10 | No | No | Historical |