Prescription drug · ANDA
Ketoconazole (Ketoconazole cream, 2%) NDC 82804-091
Ketoconazole 20 mg/g · Cream · Topical · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-091-15 | 82804009115 | 1 TUBE in 1 CARTON (82804-091-15) / 15 g in 1 TUBEMarketed from Mar 28, 2024 |
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)
- Ketoconazole
- Generic name (nonproprietary)
- ketoconazole cream, 2%
- Active ingredients
- Ketoconazole — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212443
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 82804-091_36e0bdcb-845c-452f-ad5a-a116ad657a3aSPL ID 36e0bdcb-845c-452f-ad5a-a116ad657a3aSPL set ID 36e0bdcb-845c-452f-ad5a-a116ad657a3aRxCUI 203088UNII R9400W927IUPC 0382804091157
- 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
N482804009115followed by a unit qualifier and the quantityPackage 82804-0091-15. 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 Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp . and in the treatment of seborrheic dermatitis.
Excerpt only. Read the full label for complete information.
About NDC 82804-091
- What is NDC 82804-091?
- 82804-091 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketoconazole (Ketoconazole Cream, 2%).
- What is the active ingredient?
- Ketoconazole.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ketoconazole?
- 56 other product NDCs are listed under this name. See all Ketoconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ketoconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | IPG PHARMACEUTICALS, INC. | 71085-008 | 71085-0008-45 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Amerisyn LLC | 87564-051 | 87564-0051-1087564-0051-30 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Northstar Rx LLC | 72603-878 | 72603-0878-01 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | NuCare Pharmaceuticals, Inc. | 68071-5294 | 68071-5294-04 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Amici Pharma Inc. | 69292-224 | 69292-0224-01 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Preferred Pharmaceuticals Inc. | 68788-8868 | 68788-8868-01 |
| Ketoconazole | Ketoconazole 20 mg/mL | ShampooTopical | Zydus Lifesciences Limited | 70771-1874 | 70771-1874-07 |
| Ketoconazole | Ketoconazole 20 mg/mL | ShampooTopical | Viona Pharmaceuticals Inc | 72578-156 | 72578-0156-12 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | A-S Medication Solutions | 50090-7538 | 50090-7538-00 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Cosette Pharmaceuticals, Inc. | 0713-0592 | 00713-0592-04 |
Other NDCs under ANDA 212443
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 |
|---|---|---|---|---|
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-3512 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-4236 |
| Ketoconazole Cream | Ketoconazole 20 mg/g | CreamTopical | Direct_Rx | 72189-422 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | A-S Medication Solutions | 50090-6046 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8233 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | ASCLEMED USA INC. | 87063-066 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | Sportpharm LLC | 85766-135 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-025 |