Prescription drug · UNAPPROVED DRUG OTHER
Urea 41% (Urea) NDC 59088-489
Urea 410 mg/g · Cream · Topical · PureTek Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59088-489-16 | 5908804891659088048916 | 227 g in 1 BOTTLE (59088-489-16)Marketed from Jun 7, 2022 |
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
- PureTek CorporationNDC labeler code 59088
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 59088-489_da5d8eae-8d63-d354-e053-2995a90a7999SPL ID da5d8eae-8d63-d354-e053-2995a90a7999SPL set ID da5d8eae-8d64-d354-e053-2995a90a7999RxCUI 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
N459088048916followed by a unit qualifier and the quantityPackage 59088-0489-16. 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.
About NDC 59088-489
- What is NDC 59088-489?
- 59088-489 is the product NDC for Urea 41% (urea), Urea 410 mg/g cream, listed with the FDA by PureTek Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Urea 41% (Urea).
- What is the active ingredient?
- Urea.
- Who is the labeler?
- PureTek Corporation, NDC labeler code 59088. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Urea 41%?
- 2 other product NDCs are listed under this name. See all Urea 41% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Urea 41% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Urea 41 | Urea 41 mg/g | CreamTopical | Oncora Pharma, LLC | 85477-306 | 85477-0306-27 |
| Urea 41%urea | Urea 410 mg/g | CreamTopical | Oncora Pharma, LLC | 85477-905 | 85477-0905-30 |