NDC 0378-9735

Zovirax

Acyclovir

Zovirax is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Acyclovir.

• Product ID: 0378-9735_26685154-50b5-4edf-a2fd-334f0cb4e2ca
• NDC: 0378-9735
• Product Type: Human Prescription Drug
• Proprietary Name: Zovirax
• Generic Name: Acyclovir
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-05
• Marketing End Date: 2023-02-28
• Marketing Category: NDA / NDA
• Application Number: NDA019909
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ACYCLOVIR
• Active Ingredient Strength: 200 mg/5mL
• 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

Packaging

NDC 0378-9735-73

473 mL in 1 BOTTLE (0378-9735-73)

• Marketing Start Date: 2018-10-05
• Marketing End Date: 2023-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-9735-73 [00378973573]

Zovirax SUSPENSION

• Marketing Category: NDA
• Application Number: NDA019909
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-05

Drug Details

Active Ingredients

Ingredient	Strength
ACYCLOVIR	200 mg/5mL

OpenFDA Data

• SPL SET ID: 7cc087ad-51af-4c6a-87ef-72636b67321f
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • X4HES1O11F
• RxNorm Concept Unique ID - RxCUI:
  • 307730
  • 201903

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]
• 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