What is NDC 71399-8455?

71399-8455 is the product NDC for Urea, Urea 40 g/100g lotion, listed with the FDA by AKRON PHARMA INC. It has 1 package NDC, shown above in 10- and 11-digit form.

AKRON PHARMA INC, NDC labeler code 71399. 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 71399-8455 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71399-8455Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71399-8455Add 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
71399-8455-8	7139984550871399845508	227 g in 1 BOTTLE (71399-8455-8)Marketed from Sep 13, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 g/100g
Dosage form: Lotion
Route: Topical
Labeler: AKRON PHARMA INCNDC labeler code 71399
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Sep 13, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 71399-8455_ce61c92f-c0eb-4f9b-9b7f-98cb72499e1fSPL ID ce61c92f-c0eb-4f9b-9b7f-98cb72499e1fSPL set ID 3c0d612a-2247-448d-ae65-f9abfd894158RxCUI 351155UNII 8W8T17847WUPC 0371399845580

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

N471399845508 followed by a unit qualifier and the quantity

Package 71399-8455-08. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 71399-8455

What is NDC 71399-8455?: 71399-8455 is the product NDC for Urea, Urea 40 g/100g lotion, listed with the FDA by AKRON PHARMA INC. It has 1 package NDC, 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?: AKRON PHARMA INC, NDC labeler code 71399. 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 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 400 mg/g	CreamTopical	BioComp Pharma, Inc.	44523-617	44523-0617-0144523-0617-0344523-0617-07
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