Prescription drug · UNAPPROVED DRUG OTHER
Urea 40% (Urea) NDC 39328-019
Urea 400 mg/g · Cream · Topical · Patrin Pharma, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39328-019-01 | 3932800190139328001901 | 1 BOTTLE, PLASTIC in 1 CARTON (39328-019-01) / 28.35 g in 1 BOTTLE, PLASTICMarketed from Oct 1, 2025 | |
| 39328-019-03 | 3932800190339328001903 | 85 g in 1 BOTTLE, PLASTIC (39328-019-03)Marketed from Oct 1, 2025 | |
| 39328-019-07 | 3932800190739328001907 | 198.4 g in 1 BOTTLE, PLASTIC (39328-019-07)Marketed from Oct 1, 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 40%
- Generic name (nonproprietary)
- urea
- Active ingredients
- Urea — 400 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Patrin Pharma, IncNDC labeler code 39328
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 39328-019_2a3a53e2-6a1d-4422-b058-c9799cb3fa79SPL ID 2a3a53e2-6a1d-4422-b058-c9799cb3fa79SPL set ID 53ccf801-c1c6-42c8-a511-da33c308076fRxCUI 198342UNII 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
N439328001901followed by a unit qualifier and the quantityPackage 39328-0019-01. 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 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.
About NDC 39328-019
- What is NDC 39328-019?
- 39328-019 is the product NDC for Urea 40% (urea), Urea 400 mg/g cream, listed with the FDA by Patrin Pharma, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Urea 40% (Urea).
- What is the active ingredient?
- Urea.
- Who is the labeler?
- Patrin Pharma, Inc, NDC labeler code 39328. 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 40%?
- 1 other product NDC are listed under this name. See all Urea 40% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Urea 40% 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 40urea | Urea 400 mg/g | CreamTopical | Krewe Pharma, LLC | 87021-603 | 87021-0603-04 |