Urea 40%
- Product NDC
- 39328-019
- 11-digit product format
- 393280019
- Labeler code
- 39328
- Product ID
- 39328-019_2a3a53e2-6a1d-4422-b058-c9799cb3fa79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Urea
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Patrin Pharma, Inc
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2025-10-01
- Substance
- UREA
- Active strength
- 400 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 40%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 400 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 198342 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39328-019-01 | Urea 40% | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 39328-019-01 | Urea 40% | 28.35 g in 1 BOTTLE, PLASTIC | CREAM | 28.35 | | 1 |
| 39328-019-03 | Urea 40% | 85 g in 1 BOTTLE, PLASTIC | CREAM | 85 | | 1 |
| 39328-019-07 | Urea 40% | 198.4 g in 1 BOTTLE, PLASTIC | CREAM | 198.4 | | 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 |
|---|
| 39328-019-01 | 39328001901 | 1 BOTTLE, PLASTIC in 1 CARTON (39328-019-01) / 28.35 g in 1 BOTTLE, PLASTIC | | 2025-10-01 | No | No | Historical |
| 39328-019-03 | 39328001903 | 85 g in 1 BOTTLE, PLASTIC (39328-019-03) | 85 g | 2025-10-01 | No | No | Historical |
| 39328-019-07 | 39328001907 | 198.4 g in 1 BOTTLE, PLASTIC (39328-019-07) | 198.4 g | 2025-10-01 | No | No | Historical |