NDC 70621-103

Xepi

Ozenoxacin

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

• Product ID: 70621-103_3d5877f5-d12c-429e-9e31-e0e1abb58420
• NDC: 70621-103
• Product Type: Human Prescription Drug
• Proprietary Name: Xepi
• Generic Name: Ozenoxacin
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-12-19
• Marketing Category: NDA / NDA
• Application Number: NDA208945
• Labeler Name: Biofrontera Inc.
• Substance Name: OZENOXACIN
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70621-103-03

1 TUBE in 1 CELLO PACK (70621-103-03) > 3 g in 1 TUBE

• Marketing Start Date: 2019-12-19
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 70621-103-03 [70621010303]

Xepi CREAM

• Marketing Category: NDA
• Application Number: NDA208945
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-19

NDC 70621-103-10 [70621010310]

Xepi CREAM

• Marketing Category: NDA
• Application Number: NDA208945
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-19

Drug Details

Active Ingredients

Ingredient	Strength
OZENOXACIN	10 mg/g

Pharmacological Class

• 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