What is NDC 44523-617?

44523-617 is the product NDC for Urea, Urea 400 mg/g cream, listed with the FDA by BioComp Pharma, Inc.. It has 3 package NDCs, 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?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Urea NDC 44523-617 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)44523-617Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44523-0617Add 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
44523-617-01	4452306170144523061701	1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTICMarketed from Mar 15, 2018
44523-617-03	4452306170344523061703	85 g in 1 BOTTLE, PLASTIC (44523-617-03)Marketed from Mar 15, 2018
44523-617-07	4452306170744523061707	198.4 g in 1 BOTTLE, PLASTIC (44523-617-07)Marketed from Mar 15, 2018

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
Generic name (nonproprietary): urea
Active ingredients: Urea — 400 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: Mar 15, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 44523-617_4629c716-aa54-7dc4-e063-6294a90a3decSPL ID 4629c716-aa54-7dc4-e063-6294a90a3decSPL set ID 6774a5ef-9bb0-4e7a-e053-2a91aa0af47fRxCUI 198342UNII 8W8T17847WUPC 0344523617070, 0344523617032

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

N444523061701 followed by a unit qualifier and the quantity

Package 44523-0617-01. 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 Dec 17, 2025.

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 44523-617

What is NDC 44523-617?: 44523-617 is the product NDC for Urea, Urea 400 mg/g cream, listed with the FDA by BioComp Pharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Urea.
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?: 8 other product NDCs are listed under this name. See all Urea NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Urea NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Urea	Urea 400 mg/g	LotionTopical	Cintex Services, LLC	24470-962	24470-0962-08
Urea	Urea 40 g/100g	LotionTopical	AKRON PHARMA INC	71399-8455	71399-8455-08
Urea	Urea 200 mg/g	CreamTopical	BioComp Pharma, Inc.	44523-618	44523-0618-03
Urea	Urea 400 mg/g	CreamTopical	Cintex Services, LLC	24470-939	24470-0939-0124470-0939-0324470-0939-07
Urea	Urea 40 g/100g	CreamTopical	AvPAK	50268-872	50268-0872-1950268-0872-2850268-0872-85
Urea	Urea 400 mg/g	LotionTopical	Bantry Pharma, LLC	81542-201	81542-0201-08
Urea	Urea 40 g/100g	LotionTopical	Bryant Ranch Prepack	63629-2040	63629-2040-01
Urea	Urea 39 g/100g	CreamTopical	Bryant Ranch Prepack	63629-2036	63629-2036-01