Ketoconazole NDC 16714-955

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-955Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0955Add 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
16714-955-01	16714095501	1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBEMarketed from Apr 25, 2019
16714-955-02	16714095502	1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBEMarketed from Apr 25, 2019
16714-955-03	16714095503	1 TUBE in 1 CARTON (16714-955-03) / 60 g in 1 TUBEMarketed from Apr 25, 2019

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 — 20 mg/g
Dosage form: Cream
Route: Topical
Labeler: NORTHSTAR RX LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075638
Marketing start: Dec 18, 2002
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 16714-955_494f72d9-37d0-5066-e063-6394a90a95bcSPL ID 494f72d9-37d0-5066-e063-6394a90a95bcSPL set ID bf3e48fd-e063-42e6-acd1-580ddc6e93beRxCUI 203088UNII R9400W927IUPC 0316714955025
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

N416714095501 followed by a unit qualifier and the quantity

Package 16714-0955-01. 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 Jan 26, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075638

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

FDA NDC Directory listings under ANDA 075638
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	A-S Medication Solutions	50090-6069
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Golden State Medical Supply, Inc.	51407-279
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Proficient Rx LP	63187-774
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	IPG PHARMACEUTICALS, INC.	71085-008
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	NuCare Pharmaceuticals,Inc.	68071-1709
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1298