Prescription drug · UNAPPROVED DRUG OTHER
Urea Cream 40% (Urea) NDC 16477-340
Urea 400 mg/g · Cream · Topical · Laser Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16477-340-01 | 1647703400116477034001 | 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTICMarketed from May 4, 2018 | |
| 16477-340-03 | 1647703400316477034003 | 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-03) / 85 g in 1 BOTTLE, PLASTICMarketed from May 4, 2018 | |
| 16477-340-07 | 1647703400716477034007 | 1 BOTTLE, PLASTIC in 1 CARTON (16477-340-07) / 198.4 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 40%
- Generic name (nonproprietary)
- urea
- Active ingredients
- Urea — 400 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
- Listing expires
- Identifiers
- Product ID 16477-340_42f70c2c-33ab-99df-e063-6394a90a5f86SPL ID 42f70c2c-33ab-99df-e063-6394a90a5f86SPL set ID ef2db58d-e760-417d-8574-45a411c49b47RxCUI 198342UNII 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
N416477034001followed by a unit qualifier and the quantityPackage 16477-0340-01. 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 .
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.
About NDC 16477-340
- What is NDC 16477-340?
- 16477-340 is the product NDC for Urea Cream 40% (urea), Urea 400 mg/g cream, listed with the FDA by Laser Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Urea Cream 40% (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 40%?
- 1 other product NDC are listed under this name. See all Urea Cream 40% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Urea Cream 40% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Urea Cream 40%urea | Urea 400 mg/g | CreamTopical | Akron Pharma Inc. | 71399-8456 | 71399-8456-0171399-8456-0371399-8456-07 |