Prescription drug · ANDA
Oxiconazole Nitrate NDC 51672-1359
Oxiconazole nitrate 10 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1359-1 | 51672135901 | 1 TUBE in 1 CARTON (51672-1359-1) / 15 g in 1 TUBEMarketed from Mar 7, 2016 | |
| 51672-1359-2 | 51672135902 | 1 TUBE in 1 CARTON (51672-1359-2) / 30 g in 1 TUBEMarketed from Mar 7, 2016 | |
| 51672-1359-3 | 51672135903 | 1 TUBE in 1 CARTON (51672-1359-3) / 60 g in 1 TUBEMarketed from Mar 7, 2016 | |
| 51672-1359-8 | 51672135908 | 1 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
N451672135901followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Oxiconazole Nitrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxiconazole Nitrate | Oxiconazole nitrate 10 mg/g | CreamTopical | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0358 | 00168-0358-3000168-0358-6000168-0358-90 |