Urea Cream 40 Percent (urea) NDC 58657-489

NDC codes

FDA NDC Directory

Product NDC (as listed)58657-489Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58657-0489Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
58657-489-01	58657048901	28.35 g in 1 BOTTLE (58657-489-01)Marketed from Oct 31, 2023
58657-489-03	58657048903	85 g in 1 BOTTLE (58657-489-03)Marketed from Oct 31, 2023
58657-489-07	58657048907	198.4 g in 1 BOTTLE (58657-489-07)Marketed from Jan 15, 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 Cream 40 Percent
Generic name (nonproprietary): urea
Active ingredients: Urea — 400 mg/g
Dosage form: Cream
Route: Topical
Labeler: Method Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Oct 31, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 58657-489_49ee2dc0-c081-673b-e063-6294a90aa6c6SPL ID 49ee2dc0-c081-673b-e063-6294a90aa6c6SPL set ID 0920f780-b504-1fea-e063-6394a90ae5a9RxCUI 198342UNII 8W8T17847WUPC 0358657489014

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

N458657048901 followed by a unit qualifier and the quantity

Package 58657-0489-01. 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 Jan 15, 2026.

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.

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