Prescription drug · UNAPPROVED DRUG OTHER
Urea 40 Percent (Urea) NDC 58657-487
Urea 400 mg/g · Cream · Topical · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-487-01 | 5865704870158657048701 | 28.35 g in 1 BOTTLE (58657-487-01)Marketed from Nov 15, 2021 | |
| 58657-487-03 | 5865704870358657048703 | 85 g in 1 BOTTLE (58657-487-03)Marketed from Nov 15, 2021 | |
| 58657-487-07 | 5865704870758657048707 | 198.4 g in 1 BOTTLE (58657-487-07)Marketed from Nov 15, 2021 |
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 Percent
- Generic name (nonproprietary)
- urea
- Active ingredients
- Urea — 400 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Method Pharmaceuticals, LLCNDC labeler code 58657
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 58657-487_4aad643a-b8f7-e2cb-e063-6394a90affecSPL ID 4aad643a-b8f7-e2cb-e063-6394a90affecSPL set ID d35b75e1-937d-ebc4-e053-2a95a90ac0d8RxCUI 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
N458657048701followed by a unit qualifier and the quantityPackage 58657-0487-01. 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: This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
Excerpt only. Read the full label for complete information.
About NDC 58657-487
- What is NDC 58657-487?
- 58657-487 is the product NDC for Urea 40 Percent (urea), Urea 400 mg/g cream, listed with the FDA by Method Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Urea 40 Percent (Urea).
- What is the active ingredient?
- Urea.
- Who is the labeler?
- Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 Percent?
- 3 other product NDCs are listed under this name. See all Urea 40 Percent 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 Percent 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 Percenturea | Urea 400 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-9267 | 63629-9267-01 |
| Urea 40 Percenturea | Urea 400 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2890 | 71335-2890-01 |
| Urea 40 Percenturea | Urea 400 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1668 | 72162-1668-02 |