Ketoconazole NDC 35573-433

NDC codes

FDA NDC Directory

Product NDC (as listed)35573-433Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35573-0433Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
35573-433-02	35573043302	100 TABLET in 1 BOTTLE (35573-433-02)Marketed from Apr 10, 2020
35573-433-30	35573043330	30 TABLET in 1 BOTTLE (35573-433-30)Marketed from Apr 10, 2020

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: Burel Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075912
Marketing start: Apr 10, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 35573-433_748e48d8-09d3-413c-b724-883b6b47f01eSPL ID 748e48d8-09d3-413c-b724-883b6b47f01eSPL set ID 57e81e13-b395-4dbd-b660-3038de41a838RxCUI 197853UNII R9400W927IUPC 0335573433307
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

N435573043302 followed by a unit qualifier and the quantity

Package 35573-0433-02. 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 Aug 1, 2023. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075912

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075912
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amerisyn LLC	87564-051
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-1849
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Direct Rx	72189-180
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	A-S Medication Solutions	50090-6142
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amici Pharma Inc.	69292-224