What is NDC 44523-801?

44523-801 is the product NDC for Urea 39% Cream, Urea 390 mg/g cream, listed with the FDA by BioComp Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

BioComp Pharma, Inc., NDC labeler code 44523. 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 39% Cream?

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.

Urea 39% Cream NDC 44523-801 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)44523-801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44523-0801Add 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
44523-801-08	4452308010844523080108	227 g in 1 BOTTLE (44523-801-08)Marketed from Sep 23, 2022

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 39% Cream
Generic name (nonproprietary): urea 39% cream
Active ingredients: Urea — 390 mg/g
Dosage form: Cream
Route: Topical
Labeler: BioComp Pharma, Inc.NDC labeler code 44523
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Sep 23, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 44523-801_4846ec49-3653-db3d-e063-6294a90aa815SPL ID 4846ec49-3653-db3d-e063-6294a90aa815SPL set ID e79004b9-ffbc-3d06-e053-2995a90a8cd7RxCUI 1093289UNII 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

N444523080108 followed by a unit qualifier and the quantity

Package 44523-0801-08. 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 13, 2026.

Full label on DailyMed (opens in a new tab)

About NDC 44523-801

What is NDC 44523-801?: 44523-801 is the product NDC for Urea 39% Cream, Urea 390 mg/g cream, listed with the FDA by BioComp Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Urea 39% Cream.
What is the active ingredient?: Urea.
Who is the labeler?: BioComp Pharma, Inc., NDC labeler code 44523. 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 39% Cream?: 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.