Urea 41%
- Product NDC
- 59088-489
- 11-digit product format
- 590880489
- Labeler code
- 59088
- Product ID
- 59088-489_da5d8eae-8d63-d354-e053-2995a90a7999
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- PureTek Corporation
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2022-06-07
- Substance
- UREA
- Active strength
- 410 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Urea 41%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 410 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 1436933 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59088-489-16 | Urea 41% | 227 g in 1 BOTTLE | CREAM | 227 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59088-489 | UREA 41% (UREA) CREAM [PURETEK CORPORATION] | 1 | Current NDC, Legacy NDC, 1 package rows | 20220608_da5d8eae-8d64-d354-e053-2995a90a7999.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 |
|---|
| 59088-489-16 | 59088048916 | 227 g in 1 BOTTLE (59088-489-16) | 227 g | 2022-06-07 | 0000-00-00 | No | No | Current |