Prescription drug · UNAPPROVED DRUG OTHER
Urea NDC 71399-8455
Urea 40 g/100g · Lotion · Topical · AKRON PHARMA INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71399-8455-8 | 71399845508 | 227 g in 1 BOTTLE (71399-8455-8)Marketed from Sep 13, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- urea
- Active ingredients
- Urea — 40 g/100g
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- AKRON PHARMA INC
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 71399-8455_ce61c92f-c0eb-4f9b-9b7f-98cb72499e1fSPL ID ce61c92f-c0eb-4f9b-9b7f-98cb72499e1fSPL set ID 3c0d612a-2247-448d-ae65-f9abfd894158RxCUI 351155UNII 8W8T17847WUPC 0371399845580
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
N471399845508followed by a unit qualifier and the quantityPackage 71399-8455-08. 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 and 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 eschar. 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.