ketoconazole NDC 45802-532

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-532Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0532Add 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
45802-532-32	45802053232	1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTERMarketed from Aug 30, 2011
45802-532-33	45802053233	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 Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091550
Marketing start: Aug 30, 2011
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 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

N445802053232 followed by a unit qualifier and the quantity

Package 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 Feb 29, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091550

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

FDA NDC Directory listings under ANDA 091550
Product	Strength	Form · route	Labeler	Product NDC
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	72162-1417
Ketodanketoconazole	Ketoconazole 20 mg/g	Aerosol, FoamTopical	Medimetriks Pharmaceuticals, Inc.	43538-530
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	71335-2943
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	71335-2941
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	63629-8676
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	63629-8677