Prescription drug · ANDA
Ketoconazole NDC 71335-0439
Ketoconazole 200 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0439-1 | 71335043901 | 10 TABLET in 1 BOTTLE (71335-0439-1)Marketed from Apr 28, 2010 | |
| 71335-0439-2 | 71335043902 | 30 TABLET in 1 BOTTLE (71335-0439-2)Marketed from Apr 28, 2010 | |
| 71335-0439-3 | 71335043903 | 40 TABLET in 1 BOTTLE (71335-0439-3)Marketed from Apr 28, 2010 | |
| 71335-0439-4 | 71335043904 | 60 TABLET in 1 BOTTLE (71335-0439-4)Marketed from Apr 28, 2010 | |
| 71335-0439-5 | 71335043905 | 8 TABLET in 1 BOTTLE (71335-0439-5)Marketed from Apr 28, 2010 | |
| 71335-0439-6 | 71335043906 | 7 TABLET in 1 BOTTLE (71335-0439-6)Marketed from Apr 28, 2010 | |
| 71335-0439-7 | 71335043907 | 14 TABLET in 1 BOTTLE (71335-0439-7)Marketed from Apr 28, 2010 | |
| 71335-0439-8 | 71335043908 | 90 TABLET in 1 BOTTLE (71335-0439-8)Marketed from Apr 28, 2010 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075319
- 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 71335-0439_ae8e3f89-1b77-4934-9252-64d9888d13fdSPL ID ae8e3f89-1b77-4934-9252-64d9888d13fdSPL set ID 4baebcab-a237-42c0-9183-6f447a44e371RxCUI 197853UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335043901followed by a unit qualifier and the quantityPackage 71335-0439-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the ce…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075319
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 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-020 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Direct_Rx | 72189-428 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4026 |