Prescription drug · ANDA
Ketoconazole NDC 0093-3219
Ketoconazole 20 mg/g · Cream · Topical · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3219-15 | 00093321915 | 1 TUBE in 1 CARTON (0093-3219-15) / 15 g in 1 TUBEMarketed from Feb 8, 2019 | |
| 0093-3219-30 | 00093321930 | 1 TUBE in 1 CARTON (0093-3219-30) / 30 g in 1 TUBEMarketed from Feb 8, 2019 | |
| 0093-3219-92 | 00093321992 | 1 TUBE in 1 CARTON (0093-3219-92) / 60 g in 1 TUBEMarketed from Feb 8, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Active ingredients
- Ketoconazole — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075581
- 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 0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0fSPL ID 3027539e-261c-4ac2-a25d-c41fcce3da0fSPL set ID 7fc47a6a-3714-4598-ae3b-d5a229262c21RxCUI 203088UNII R9400W927I
- 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
N400093321915followed by a unit qualifier and the quantityPackage 00093-3219-15. 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 .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075581
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 |
|---|---|---|---|---|
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8819 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8820 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | A-S Medication Solutions | 50090-5265 |