Uredex (urea) NDC 85622-601

NDC codes

FDA NDC Directory

Product NDC (as listed)85622-601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85622-0601Add 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	Copy
85622-601-03	85622060103	85 g in 1 BOTTLE, PLASTIC (85622-601-03)Marketed from Jan 7, 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): Uredex
Generic name (nonproprietary): urea
Active ingredients: Urea — 200 mg/g
Dosage form: Cream
Route: Topical
Labeler: Blue Heron Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 7, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 85622-601_979c3a57-d848-4a91-bed7-517717396645SPL ID 979c3a57-d848-4a91-bed7-517717396645SPL set ID 0e4d7b03-527f-4cff-9154-7e5e485a8f80RxCUI 198886UNII 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

N485622060103 followed by a unit qualifier and the quantity

Package 85622-0601-03. 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 Jul 13, 2026.

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.

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