What is NDC 0168-0358?

0168-0358 is the product NDC for Oxiconazole Nitrate, Oxiconazole nitrate 10 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 Oxiconazole Nitrate?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxiconazole Nitrate NDC 0168-0358 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0358Add 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
0168-0358-30	0016803583000168035830	30 g in 1 TUBE (0168-0358-30)Marketed from Mar 9, 2016
0168-0358-60	0016803586000168035860	60 g in 1 TUBE (0168-0358-60)Marketed from Mar 9, 2016
0168-0358-90	0016803589000168035890	90 g in 1 TUBE (0168-0358-90)Marketed from Mar 10, 2016

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): Oxiconazole Nitrate
Generic name (nonproprietary): oxiconazole nitrate
Active ingredients: Oxiconazole nitrate — 10 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: NDA authorized genericApplication NDA 019828
Marketing start: Mar 9, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 0168-0358_413f9391-fa2d-4449-b25d-fd11376f231eSPL ID 413f9391-fa2d-4449-b25d-fd11376f231eSPL set ID aa368d2b-a5d2-49dd-86e1-5693b68b46f4RxCUI 312139UNII RQ8UL4C17SUPC 0301680358307
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

N400168035830 followed by a unit qualifier and the quantity

Package 00168-0358-30. 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 Jan 28, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ). Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0168-0358

What is NDC 0168-0358?: 0168-0358 is the product NDC for Oxiconazole Nitrate, Oxiconazole nitrate 10 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?: Oxiconazole Nitrate.
What is the active ingredient?: Oxiconazole nitrate.
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 Oxiconazole Nitrate?: 1 other product NDC are listed under this name. See all Oxiconazole Nitrate 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 Oxiconazole Nitrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxiconazole Nitrate	Oxiconazole nitrate 10 mg/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1359	51672-1359-0151672-1359-0251672-1359-03+1 more