NDC 0168-0358

Oxiconazole Nitrate

Oxiconazole Nitrate

Oxiconazole Nitrate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Oxiconazole Nitrate.

• Product ID: 0168-0358_ced09ac9-d81c-4812-905e-80abec8141da
• NDC: 0168-0358
• Product Type: Human Prescription Drug
• Proprietary Name: Oxiconazole Nitrate
• Generic Name: Oxiconazole Nitrate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-03-09
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA019828
• Labeler Name: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• Substance Name: OXICONAZOLE NITRATE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0168-0358-30

30 g in 1 TUBE (0168-0358-30)

• Marketing Start Date: 2016-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0358-30 [00168035830]

Oxiconazole Nitrate CREAM

• Marketing Category: NDA authorized generic
• Application Number: NDA019828
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-03-09

NDC 0168-0358-90 [00168035890]

Oxiconazole Nitrate CREAM

• Marketing Category: NDA authorized generic
• Application Number: NDA019828
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-03-10

NDC 0168-0358-60 [00168035860]

Oxiconazole Nitrate CREAM

• Marketing Category: NDA authorized generic
• Application Number: NDA019828
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-03-09

Drug Details

Active Ingredients

Ingredient	Strength
OXICONAZOLE NITRATE	10 mg/g

OpenFDA Data

• SPL SET ID: aa368d2b-a5d2-49dd-86e1-5693b68b46f4
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • RQ8UL4C17S
• RxNorm Concept Unique ID - RxCUI:
  • 312139
• UPC Code:
  • 0301680358307

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "Oxiconazole Nitrate" or generic name "Oxiconazole Nitrate"

NDC	Brand Name	Generic Name
0168-0358	Oxiconazole Nitrate	Oxiconazole Nitrate
51672-1359	Oxiconazole Nitrate	Oxiconazole Nitrate
10337-358	Oxistat	oxiconazole nitrate
10337-359	Oxistat	oxiconazole nitrate
21695-459	Oxistat	oxiconazole nitrate
62559-285	Oxistat	oxiconazole nitrate