UREDEX
- Product NDC
- 85622-601
- 11-digit product format
- 856220601
- Labeler code
- 85622
- Product ID
- 85622-601_08af3450-45c1-4a9c-ba34-b2db7d605f5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- UREA
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Blue Heron Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-01-07
- Substance
- UREA
- Active strength
- 200 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UREDEX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UREA | 200 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8W8T17847W |
| Rxcui | 198886 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85622-601-03 | UREDEX | 85 g in 1 BOTTLE, PLASTIC | CREAM | 85 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85622-601-03 | 85622060103 | 85 g in 1 BOTTLE, PLASTIC (85622-601-03) | 85 g | 2026-01-07 | No | No | Current |