Ketoconazole NDC 63629-8675

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8675Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8675Add 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
63629-8675-1	63629867501	120 mL in 1 BOTTLE (63629-8675-1)Marketed from Feb 9, 2022

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 — 20 mg/mL
Dosage form: Shampoo, Suspension
Route: Topical
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076419
Marketing start: Jan 19, 2010
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 63629-8675_01cb5b3b-9fb1-44a8-92a1-1954ba3968a6SPL ID 01cb5b3b-9fb1-44a8-92a1-1954ba3968a6SPL set ID b200ef76-5ea1-4253-bea5-1e8db0294510RxCUI 106336UNII 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

N463629867501 followed by a unit qualifier and the quantity

Package 63629-8675-01. 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 Mar 15, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076419

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

FDA NDC Directory listings under ANDA 076419
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Bryant Ranch Prepack	72162-1409
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	NuCare Pharmaceuticals,Inc.	68071-3930
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	NuCare Pharmaceuticals, Inc.	68071-5294
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Padagis Israel Pharmaceuticals Ltd	45802-465
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Bryant Ranch Prepack	71335-2839
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Northstar Rx LLC	72603-878