NDC codes

FDA NDC Directory
Product NDC (as listed)51672-1359Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-1359Add 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 NDC11-digit (billing)PackageCopy
51672-1359-1516721359011 TUBE in 1 CARTON (51672-1359-1) / 15 g in 1 TUBEMarketed from Mar 7, 2016
51672-1359-2516721359021 TUBE in 1 CARTON (51672-1359-2) / 30 g in 1 TUBEMarketed from Mar 7, 2016
51672-1359-3516721359031 TUBE in 1 CARTON (51672-1359-3) / 60 g in 1 TUBEMarketed from Mar 7, 2016
51672-1359-8516721359081 TUBE in 1 CARTON (51672-1359-8) / 90 g in 1 TUBEMarketed from Mar 7, 2016

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)
Oxiconazole Nitrate
Generic name (nonproprietary)
oxiconazole nitrate
Active ingredients
Oxiconazole nitrate — 10 mg/g
Dosage form
Cream
Route
Topical
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205076
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 51672-1359_38efa4f4-a3f2-fd03-e063-6394a90aac00SPL ID 38efa4f4-a3f2-fd03-e063-6394a90aac00SPL set ID 04477378-cccc-4db3-9e1b-5c1d6a00bd13RxCUI 312139UNII RQ8UL4C17S
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

N451672135901 followed by a unit qualifier and the quantity

Package 51672-1359-01. 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 .

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 bel…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-1359

What is NDC 51672-1359?
51672-1359 is the product NDC for Oxiconazole Nitrate, Oxiconazole nitrate 10 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Oxiconazole NitrateOxiconazole nitrate 10 mg/gCreamTopicalE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0168-035800168-0358-3000168-0358-6000168-0358-90

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