Over-the-counter drug · UNAPPROVED DRUG OTHER
Urea 40 (Urea) NDC 87021-603
Urea 400 mg/g · Cream · Topical · Krewe Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87021-603-04 | 8702106030487021060304 | 1 JAR in 1 JAR (87021-603-04) / 113 g in 1 JARMarketed from Jun 4, 2026 |
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
- Krewe Pharma, LLCNDC labeler code 87021
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 87021-603_74f07bb6-27de-49ad-bfc6-5ea8074e57afSPL ID 74f07bb6-27de-49ad-bfc6-5ea8074e57afSPL set ID 415c4efd-95bd-4276-900c-e9da70266cd4RxCUI 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
N487021060304followed by a unit qualifier and the quantityPackage 87021-0603-04. 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)
Usage: Intensely exfolitating and skin-softening cream with Urea 40%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.
Excerpt only. Read the full label for complete information.
About NDC 87021-603
- What is NDC 87021-603?
- 87021-603 is the product NDC for Urea 40 (urea), Urea 400 mg/g cream, listed with the FDA by Krewe Pharma, LLC. It has 1 package NDC, 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?
- Krewe Pharma, LLC, NDC labeler code 87021. 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 40%urea | Urea 400 mg/g | CreamTopical | Patrin Pharma, Inc | 39328-019 | 39328-0019-0139328-0019-0339328-0019-07 |