What is NDC 16477-341?

16477-341 is the product NDC for Urea Cream 41% (urea), Urea 410 mg/g cream, listed with the FDA by Laser Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Laser Pharmaceuticals, LLC, NDC labeler code 16477. 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 Cream 41%?

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 Cream 41% NDC 16477-341 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16477-341Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16477-0341Add 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
16477-341-08	1647703410816477034108	1 BOTTLE, PLASTIC in 1 CARTON (16477-341-08) / 227 g in 1 BOTTLE, PLASTICMarketed from May 4, 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 Cream 41%
Generic name (nonproprietary): urea
Active ingredients: Urea — 410 mg/g
Dosage form: Cream
Route: Topical
Labeler: Laser Pharmaceuticals, LLCNDC labeler code 16477
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: May 4, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 16477-341_42f7100f-e9e2-69fd-e063-6294a90a0f68SPL ID 42f7100f-e9e2-69fd-e063-6294a90a0f68SPL set ID ada4d313-1050-4501-9c93-68dfb3a2c9e4RxCUI 1436933UNII 8W8T17847WUPC 0316477341080

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

N416477034108 followed by a unit qualifier and the quantity

Package 16477-0341-08. 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 Nov 6, 2025.

Indications (excerpt from the label)

Indications and Usage 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 eshar. 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 16477-341

What is NDC 16477-341?: 16477-341 is the product NDC for Urea Cream 41% (urea), Urea 410 mg/g cream, listed with the FDA by Laser Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Urea Cream 41% (Urea).
What is the active ingredient?: Urea.
Who is the labeler?: Laser Pharmaceuticals, LLC, NDC labeler code 16477. 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 Cream 41%?: 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.

Urea Cream 41% (Urea) NDC 16477-341