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 NDC11-digit (billing)PackageCopy
85622-601-03856220601038562206010385 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, LLCNDC labeler code 85622
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
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 .

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.

Full label on DailyMed (opens in a new tab)

About NDC 85622-601

What is NDC 85622-601?
85622-601 is the product NDC for Uredex (urea), Urea 200 mg/g cream, listed with the FDA by Blue Heron Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Uredex (Urea).
What is the active ingredient?
Urea.
Who is the labeler?
Blue Heron Pharmaceuticals, LLC, NDC labeler code 85622. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Uredex?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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