Prescription drug · ANDA
Ketoconazole (Ketoconazole foam) NDC 70700-160
Ketoconazole 20 mg/g · Aerosol, Foam · Topical · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-160-19 | 7070001601970700016019 | 50 g in 1 CAN (70700-160-19)Marketed from May 21, 2021 | |
| 70700-160-20 | 7070001602070700016020 | 100 g in 1 CAN (70700-160-20)Marketed from May 21, 2021 |
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 foam
- Active ingredients
- Ketoconazole — 20 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Xiromed, LLCNDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213601
- 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 70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69SPL ID 1d2842b4-06d6-8054-d485-cb30f0ed4f69SPL set ID ea319889-5e58-f778-3009-5ba6a5f2690aRxCUI 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
N470700016019followed by a unit qualifier and the quantityPackage 70700-0160-19. 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 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 for treatment of fungal infections have not been established.
Excerpt only. Read the full label for complete information.
About NDC 70700-160
- What is NDC 70700-160?
- 70700-160 is the product NDC for Ketoconazole (ketoconazole foam), Ketoconazole 20 mg/g aerosol, foam, listed with the FDA by Xiromed, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketoconazole (Ketoconazole Foam).
- What is the active ingredient?
- Ketoconazole.
- Who is the labeler?
- Xiromed, LLC, NDC labeler code 70700. 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 |