Prescription drug · ANDA
ketoconazole NDC 45802-532
Ketoconazole 2 g/100g · Aerosol, Foam · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-532-32 | 4580205323245802053232 | 1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTERMarketed from Aug 30, 2011 | |
| 45802-532-33 | 4580205323345802053233 | 1 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTERMarketed from Aug 30, 2011 |
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
- Active ingredients
- Ketoconazole — 2 g/100g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- 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 45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9SPL ID f9768109-216c-49f3-be2a-d0c3eac142b9SPL set ID 9b65f632-a98d-400e-9ec3-84dea581d6a3RxCUI 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
N445802053232followed by a unit qualifier and the quantityPackage 45802-0532-32. 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.
About NDC 45802-532
- What is NDC 45802-532?
- 45802-532 is the product NDC for ketoconazole, Ketoconazole 2 g/100g aerosol, foam, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ketoconazole.
- What is the active ingredient?
- Ketoconazole.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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?
- 54 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 | NuCare Pharmaceuticals, Inc. | 68071-5294 | 68071-5294-04 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Northstar Rx LLC | 72603-878 | 72603-0878-01 |
| 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 | Cosette Pharmaceuticals, Inc. | 0713-0592 | 00713-0592-04 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | A-S Medication Solutions | 50090-7538 | 50090-7538-00 |
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 |
|---|---|---|---|---|
| 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 | Bryant Ranch Prepack | 71335-2941 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Bryant Ranch Prepack | 71335-2943 |
| ketoconazole | Ketoconazole 2 g/100g | Aerosol, FoamTopical | Bryant Ranch Prepack | 72162-1417 |
| Ketodanketoconazole | Ketoconazole 20 mg/g | Aerosol, FoamTopical | Medimetriks Pharmaceuticals, Inc. | 43538-530 |