NDC 70363-011

Xepi

Ozenoxacin

Xepi is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Cutanea Life Sciences, Inc.. The primary component is Ozenoxacin.

• Product ID: 70363-011_4fe6bca5-6a38-4416-af93-5af8aab13d5b
• NDC: 70363-011
• Product Type: Human Prescription Drug
• Proprietary Name: Xepi
• Generic Name: Ozenoxacin
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-10-05
• Marketing Category: NDA / NDA
• Application Number: NDA208945
• Labeler Name: Cutanea Life Sciences, Inc.
• Substance Name: OZENOXACIN
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 70363-011-04

1 TUBE in 1 BOX (70363-011-04) > 3 g in 1 TUBE

• Marketing Start Date: 2018-10-05
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 70363-011-04 [70363001104]

Xepi CREAM

• Marketing Category: NDA
• Application Number: NDA208945
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-05

NDC 70363-011-30 [70363001130]

Xepi CREAM

• Marketing Category: NDA
• Application Number: NDA208945
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-10-05

Drug Details

Active Ingredients

Ingredient	Strength
OZENOXACIN	10 mg/g

OpenFDA Data

• SPL SET ID: 3361dd6c-4b03-4c42-9b95-4ecd43c34294
• Manufacturer:
  • Cutanea Life Sciences, Inc.
• UNII:
  • V0LH498RFO
• RxNorm Concept Unique ID - RxCUI:
  • 1994745
  • 1994750

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]
• Quinolone Antimicrobial [EPC]
• Quinolones [CS]

NDC Crossover Matching brand name "Xepi" or generic name "Ozenoxacin"

NDC	Brand Name	Generic Name
70363-011	Xepi	ozenoxacin
70621-103	Xepi	ozenoxacin