What is NDC 43538-530?

43538-530 is the product NDC for Ketodan (ketoconazole), Ketoconazole 20 mg/g aerosol, foam, listed with the FDA by Medimetriks Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Medimetriks Pharmaceuticals, Inc., NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ketodan?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ketodan NDC 43538-530 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43538-530Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43538-0530Add 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
43538-530-10	4353805301043538053010	1 CAN in 1 CARTON (43538-530-10) / 100 g in 1 CANMarketed from Jun 15, 2012

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): Ketodan
Generic name (nonproprietary): ketoconazole
Active ingredients: Ketoconazole — 20 mg/g
Dosage form: Aerosol, Foam
Route: Topical
Labeler: Medimetriks Pharmaceuticals, Inc.NDC labeler code 43538
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091550
Marketing start: Jun 15, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 43538-530_354d4926-b665-4e7e-a86a-5baae165a470SPL ID 354d4926-b665-4e7e-a86a-5baae165a470SPL set ID 62f19bd8-926e-4e6b-9097-d81b894b95ccRxCUI 728550, 1300272UNII 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

N443538053010 followed by a unit qualifier and the quantity

Package 43538-0530-10. 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 Dec 5, 2024.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Ketodan ® Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Ketodan ® 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 Ketodan ® Foam, 2% for treatment of fungal infections have not been established. Limitations of Use Safety and efficacy of Ketodan ® 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)

About NDC 43538-530

What is NDC 43538-530?: 43538-530 is the product NDC for Ketodan (ketoconazole), Ketoconazole 20 mg/g aerosol, foam, listed with the FDA by Medimetriks Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ketodan (Ketoconazole).
What is the active ingredient?: Ketoconazole.
Who is the labeler?: Medimetriks Pharmaceuticals, Inc., NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketodan?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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	Padagis Israel Pharmaceuticals Ltd	45802-532
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	63629-8676
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	63629-8677
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	71335-2941
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	71335-2943
ketoconazole	Ketoconazole 2 g/100g	Aerosol, FoamTopical	Bryant Ranch Prepack	72162-1417

Ketodan (Ketoconazole) NDC 43538-530