What is NDC 0168-0099?

0168-0099 is the product NDC for ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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?

54 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ketoconazole NDC 0168-0099 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0099Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0099Add 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
0168-0099-15	0016800991500168009915	1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBEMarketed from Apr 28, 2004
0168-0099-30	0016800993000168009930	1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBEMarketed from Apr 28, 2004
0168-0099-60	0016800996000168009960	1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBEMarketed from Apr 28, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076294
Marketing start: Apr 28, 2004
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 0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11SPL ID 6eaf555f-3e9c-4811-ae1f-66afda8b2b11SPL set ID cad7c647-34a9-4e4e-83b3-8d78e58f588fRxCUI 203088UNII R9400W927IUPC 0301680099156
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

N400168009915 followed by a unit qualifier and the quantity

Package 00168-0099-15. 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 28, 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)

About NDC 0168-0099

What is NDC 0168-0099?: 0168-0099 is the product NDC for ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: ketoconazole.
What is the active ingredient?: Ketoconazole.
Who is the labeler?: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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?: 54 other product NDCs are listed under this name. See all ketoconazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other ketoconazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	IPG PHARMACEUTICALS, INC.	71085-008	71085-0008-45
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amerisyn LLC	87564-051	87564-0051-1087564-0051-30
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	NuCare Pharmaceuticals, Inc.	68071-5294	68071-5294-04
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Northstar Rx LLC	72603-878	72603-0878-01
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amici Pharma Inc.	69292-224	69292-0224-01
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Preferred Pharmaceuticals Inc.	68788-8868	68788-8868-01
Ketoconazole	Ketoconazole 20 mg/mL	ShampooTopical	Zydus Lifesciences Limited	70771-1874	70771-1874-07
Ketoconazole	Ketoconazole 20 mg/mL	ShampooTopical	Viona Pharmaceuticals Inc	72578-156	72578-0156-12
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Cosette Pharmaceuticals, Inc.	0713-0592	00713-0592-04
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	A-S Medication Solutions	50090-7538	50090-7538-00

All 55 ketoconazole NDCs