NDC 0187-0994

Zovirax

Acyclovir

Zovirax 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.

• Product ID: 0187-0994_60b45e69-21f5-42a1-a2fd-24df2f9c9632
• NDC: 0187-0994
• Product Type: Human Prescription Drug
• Proprietary Name: Zovirax
• Generic Name: Acyclovir
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2002-12-30
• Marketing Category: NDA / NDA
• Application Number: NDA021478
• Labeler Name: Valeant Pharmaceuticals North America LLC
• Substance Name: ACYCLOVIR
• Active Ingredient Strength: 50 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0187-0994-45

1 TUBE in 1 CARTON (0187-0994-45) > 5 g in 1 TUBE

• Marketing Start Date: 2002-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-0994-20 [00187099420]

Zovirax CREAM

• Marketing Category: NDA
• Application Number: NDA021478
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-12-30
• Marketing End Date: 2015-05-31

NDC 0187-0994-45 [00187099445]

Zovirax CREAM

• Marketing Category: NDA
• Application Number: NDA021478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2002-12-30

Drug Details

Active Ingredients

Ingredient	Strength
ACYCLOVIR	50 mg/g

OpenFDA Data

• SPL SET ID: 125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • X4HES1O11F
• RxNorm Concept Unique ID - RxCUI:
  • 825321
  • 141859

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]

NDC Crossover Matching brand name "Zovirax" or generic name "Acyclovir"

NDC	Brand Name	Generic Name
0187-0993	Zovirax	acyclovir
0187-0994	Zovirax	acyclovir
0378-9735	Zovirax	Acyclovir
40076-949	ZOVIRAX	ZOVIRAX
40076-991	ZOVIRAX	ZOVIRAX
40076-953	ZOVIRAX	ZOVIRAX
40076-945	ZOVIRAX	ZOVIRAX
42254-149	ZOVIRAX	ZOVIRAX
0093-3630	Acyclovir	acyclovir
0093-8940	Acyclovir	Acyclovir
0093-8943	Acyclovir	Acyclovir
0093-8947	Acyclovir	Acyclovir
0143-9657	Acyclovir	Acyclovir
0143-9658	Acyclovir	Acyclovir
0168-0825	acyclovir	acyclovir
0378-8700	Acyclovir	acyclovir
0378-8712	Acyclovir	Acyclovir
0440-6030	Acyclovir	Acyclovir
0440-7033	acyclovir	acyclovir
0472-0082	Acyclovir	Acyclovir
0591-1159	Acyclovir	acyclovir
0713-0630	Acyclovir	Acyclovir
0904-5789	ACYCLOVIR	ACYCLOVIR
0904-5790	acyclovir	acyclovir
10544-039	Acyclovir	acyclovir
10544-089	Acyclovir	acyclovir
10544-101	Acyclovir	Acyclovir