NDC 0187-5104

Xerese

Acyclovir And Hydrocortisone

Xerese is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Acyclovir; Hydrocortisone.

• Product ID: 0187-5104_55989c60-a53f-45fe-a543-894782c85f91
• NDC: 0187-5104
• Product Type: Human Prescription Drug
• Proprietary Name: Xerese
• Generic Name: Acyclovir And Hydrocortisone
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA022436
• Labeler Name: Valeant Pharmaceuticals North America LLC
• Substance Name: ACYCLOVIR; HYDROCORTISONE
• Active Ingredient Strength: 50 mg/g; mg/g
• Pharm Classes: DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0187-5104-01

1 TUBE in 1 CARTON (0187-5104-01) > 5 g in 1 TUBE

• Marketing Start Date: 2009-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-5104-01 [00187510401]

Xerese CREAM

• Marketing Category: NDA
• Application Number: NDA022436
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-07-31

NDC 0187-5104-02 [00187510402]

Xerese CREAM

• Marketing Category: NDA
• Application Number: NDA022436
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-31

Drug Details

Active Ingredients

Ingredient	Strength
ACYCLOVIR	50 mg/g

OpenFDA Data

• SPL SET ID: 3b6ac164-0f1e-4f36-94a1-1fdb07d710f5
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • X4HES1O11F
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 998426
  • 998422
• UPC Code:
  • 0301875104016

Pharmacological Class

• DNA Polymerase Inhibitors [MoA]
• Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]