Prescription drug · UNAPPROVED DRUG OTHER
Urea 41% (urea) NDC 85477-905
Urea 410 mg/g · Cream · Topical · Oncora Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85477-905-30 | 85477090530 | 227 g in 1 BOTTLE (85477-905-30)Marketed from Jun 11, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Urea 41%
- Generic name (nonproprietary)
- urea
- Active ingredients
- Urea — 410 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Oncora Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 85477-905_37576876-738d-ac79-e063-6394a90a84feSPL ID 37576876-738d-ac79-e063-6394a90a84feSPL set ID 37576876-738c-ac79-e063-6394a90a84feRxCUI 1436933UNII 8W8T17847W
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485477090530followed by a unit qualifier and the quantityPackage 85477-0905-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.
Excerpt only. Read the full label for complete information.