Prescription drug · UNAPPROVED DRUG OTHER
Urea NDC 50268-872
Urea 40 g/100g · Cream · Topical · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-872-19 | 5026808721950268087219 | 198.4 g in 1 BOTTLE (50268-872-19)Marketed from Feb 24, 2023 | |
| 50268-872-28 | 5026808722850268087228 | 28.35 g in 1 TUBE (50268-872-28)Marketed from Jul 13, 2022 | |
| 50268-872-85 | 5026808728550268087285 | 85 g in 1 TUBE (50268-872-85)Marketed from Feb 24, 2023 |
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 — 40 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 50268-872_34145ca3-6034-8c33-e063-6394a90acb55SPL ID 34145ca3-6034-8c33-e063-6394a90acb55SPL set ID e3b31a1c-8be2-29f6-e053-2a95a90af526RxCUI 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
N450268087219followed by a unit qualifier and the quantityPackage 50268-0872-19. 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 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.
About NDC 50268-872
- What is NDC 50268-872?
- 50268-872 is the product NDC for Urea, Urea 40 g/100g cream, listed with the FDA by AvPAK. 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?
- 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?
- 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.
Related NDCs: other Urea 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 | 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 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 |