Prescription drug · NDA
Exelderm (Sulconazole nitrate) NDC 69489-711
Sulconazole nitrate 10 mg/g · Cream · Topical · Journey Medical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69489-711-60 | 69489071160 | 1 TUBE in 1 CARTON (69489-711-60) / 60 g in 1 TUBEMarketed from Jun 7, 2019 |
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)
- Exelderm
- Generic name (nonproprietary)
- sulconazole nitrate
- Active ingredients
- Sulconazole nitrate — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Journey Medical CorporationNDC labeler code 69489
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018737
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 69489-711_f03361cb-005c-4d0c-bc27-033484f02624SPL ID f03361cb-005c-4d0c-bc27-033484f02624SPL set ID 1d822e06-f37e-4984-8365-efd4c4451478RxCUI 106366, 208117UNII 1T89100D5U
- Pharmacologic class
- Azole Antifungal
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
N469489071160followed by a unit qualifier and the quantityPackage 69489-0711-60. 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 EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections.
Excerpt only. Read the full label for complete information.
About NDC 69489-711
- What is NDC 69489-711?
- 69489-711 is the product NDC for Exelderm (sulconazole nitrate), Sulconazole nitrate 10 mg/g cream, listed with the FDA by Journey Medical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exelderm (Sulconazole Nitrate).
- What is the active ingredient?
- Sulconazole nitrate.
- Who is the labeler?
- Journey Medical Corporation, NDC labeler code 69489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exelderm?
- 1 other product NDC are listed under this name. See all Exelderm NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exelderm products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exeldermsulconazole nitrate | Sulconazole nitrate 10 mg/mL | SolutionTopical | Journey Medical Corporation | 69489-721 | 69489-0721-30 |
Other NDCs under NDA 018737
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sulconazole Nitrate | Sulconazole nitrate 10 mg/g | CreamTopical | JG Pharma | 72143-311 |