Over-the-counter drug · UNAPPROVED DRUG OTHER
Urea 20 (Urea) NDC 50268-820
Urea 200 mg/g · Gel · Topical · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-820-85 | 5026808208550268082085 | 1 TUBE in 1 CARTON (50268-820-85) / 85 g in 1 TUBEMarketed from Sep 19, 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 20
- Generic name (nonproprietary)
- urea
- Active ingredients
- Urea — 200 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 50268-820_48379414-bcb9-1797-e063-6394a90aa8fdSPL ID 48379414-bcb9-1797-e063-6394a90aa8fdSPL set ID e994fa05-a457-2555-e053-2a95a90ae83bUNII 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
N450268082085followed by a unit qualifier and the quantityPackage 50268-0820-85. 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)
Usage: Soothes, Softens and Moisturizes Dry Rough Skin.
Excerpt only. Read the full label for complete information.
About NDC 50268-820
- What is NDC 50268-820?
- 50268-820 is the product NDC for Urea 20 (urea), Urea 200 mg/g gel, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Urea 20 (Urea).
- What is the active ingredient?
- Urea.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. 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 20?
- 1 other product NDC are listed under this name. See all Urea 20 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Urea 20 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 20% | Urea 200 mg/g | CreamTopical | PureTek Corporation | 59088-258 | 59088-0258-16 |