Urea 39.5%
- Product NDC
- 59088-698
- 11-digit product format
- 590880698
- Labeler code
- 59088
- Product ID
- 59088-698_ea2adf3e-cea5-43b2-e053-2995a90a89a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- PureTek Corporation
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2023-01-20
- Substance
- UREA
- Active strength
- 395 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 39.5%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 395 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 2627282 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59088-698-16 | Urea 39.5% | 227 g in 1 JAR | CREAM | 227 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59088-698 | UREA 39.5% (UREA) CREAM [PURETEK CORPORATION] | 1 | Current NDC, 1 package rows | 20230124_ea2adf3e-cea6-43b2-e053-2995a90a89a6.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 |
|---|
| 59088-698-16 | 59088069816 | 227 g in 1 JAR (59088-698-16) | 227 g | 2023-01-20 | No | No | Current |