Prescription drug · ANDA
ketoconazole NDC 72162-1417
Ketoconazole 2 g/100g · Aerosol, Foam · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1417-1 | 72162141701 | 1 CANISTER in 1 CARTON (72162-1417-1) / 100 g in 1 CANISTERMarketed from Dec 24, 2024 | |
| 72162-1417-2 | 72162141702 | 1 CANISTER in 1 CARTON (72162-1417-2) / 50 g in 1 CANISTERMarketed from Dec 24, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 g/100g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091550
- 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 72162-1417_251364c4-cb46-490e-a6e4-bb95737322a8SPL ID 251364c4-cb46-490e-a6e4-bb95737322a8SPL set ID ac98307e-315a-4fbd-81cb-cd936f2bfbaeRxCUI 728550UNII 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
N472162141701followed by a unit qualifier and the quantityPackage 72162-1417-01. 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)
Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established. Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older ( 1 ). Limitations of Use Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091550
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 |
|---|---|---|---|---|
| Ketodanketoconazole | Ketoconazole 20 mg/g | Aerosol, FoamTopical | Medimetriks Pharmaceuticals, Inc. | 43538-530 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Bryant Ranch Prepack | 71335-2943 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Bryant Ranch Prepack | 71335-2941 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Bryant Ranch Prepack | 63629-8676 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Bryant Ranch Prepack | 63629-8677 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-532 |