Urea 41%
- Product NDC
- 85477-905
- 11-digit product format
- 854770905
- Labeler code
- 85477
- Product ID
- 85477-905_37576876-738d-ac79-e063-6394a90a84fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oncora Pharma, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2025-06-11
- 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 |
|---|
| 85477-905-30 | Urea 41% | 227 g in 1 BOTTLE | CREAM | 227 | | 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 |
|---|
| 85477-905-30 | 85477090530 | 227 g in 1 BOTTLE (85477-905-30) | 227 g | 2025-06-11 | No | No | Current |