Prescription drug · ANDA
Ketoconazole NDC 87564-051
Ketoconazole 200 mg/1 · Tablet · Oral · Amerisyn LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87564-051-10 | 8756400511087564005110 | 100 TABLET in 1 BOTTLE (87564-051-10)Marketed from Aug 6, 2026 | |
| 87564-051-30 | 8756400513087564005130 | 30 TABLET in 1 BOTTLE (87564-051-30)Marketed from Aug 6, 2026 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amerisyn LLCNDC labeler code 87564
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075912
- 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 87564-051_58b7a33f-9abe-2bcb-e063-6394a90ae4f1SPL ID 58b7a33f-9abe-2bcb-e063-6394a90ae4f1SPL set ID 1d598696-c6f3-4b7c-ad73-949d2089df35RxCUI 197853UNII R9400W927IUPC 0387564051106
- 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
N487564005110followed by a unit qualifier and the quantityPackage 87564-0051-10. 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.
About NDC 87564-051
- What is NDC 87564-051?
- 87564-051 is the product NDC for Ketoconazole, Ketoconazole 200 mg/1 tablet, listed with the FDA by Amerisyn LLC. 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?
- Amerisyn LLC, NDC labeler code 87564. 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 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 |
| Ketoconazoleketoconazole cream, 2% | Ketoconazole 20 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-4236 | 70518-4236-00 |
Other NDCs under ANDA 075912
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 | Burel Pharmaceuticals, LLC | 35573-433 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-6142 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Amici Pharma Inc. | 69292-224 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1849 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Direct Rx | 72189-180 |