What is NDC 72189-422?

72189-422 is the product NDC for Ketoconazole Cream, Ketoconazole 20 mg/g cream, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ketoconazole Cream?

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.

Ketoconazole Cream NDC 72189-422 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0422Add 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
72189-422-30	72189042230	30 g in 1 TUBE (72189-422-30)Marketed from Feb 7, 2023

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 Cream
Generic name (nonproprietary): ketoconazole cream
Active ingredients: Ketoconazole — 20 mg/g
Dosage form: Cream
Route: Topical
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212443
Marketing start: Feb 7, 2023
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 72189-422_4d3a9c62-805c-df8c-e063-6294a90aa498SPL ID 4d3a9c62-805c-df8c-e063-6294a90aa498SPL set ID f422aaa8-3cce-5989-e053-2a95a90a5205RxCUI 203088UNII 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

N472189042230 followed by a unit qualifier and the quantity

Package 72189-0422-30. 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 17, 2026.

Indications (excerpt from the label)

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); and 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)

About NDC 72189-422

What is NDC 72189-422?: 72189-422 is the product NDC for Ketoconazole Cream, Ketoconazole 20 mg/g cream, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ketoconazole Cream.
What is the active ingredient?: Ketoconazole.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketoconazole Cream?: 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 212443

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

FDA NDC Directory listings under ANDA 212443
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-025
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	A-S Medication Solutions	50090-6046
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	NuCare Pharmaceuticals,Inc.	68071-3512
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8233
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	REMEDYREPACK INC.	70518-4236
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	Proficient Rx LP	82804-091
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	Sportpharm LLC	85766-135
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	ASCLEMED USA INC.	87063-066