NDC 0173-0565

VALTREX

Valacyclovir Hydrochloride

VALTREX is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Valacyclovir Hydrochloride.

• Product ID: 0173-0565_1e46b07d-85da-4b7b-9067-971433f5e3e8
• NDC: 0173-0565
• Product Type: Human Prescription Drug
• Proprietary Name: VALTREX
• Generic Name: Valacyclovir Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2002-08-12
• Marketing Category: NDA / NDA
• Application Number: NDA020487
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: VALACYCLOVIR HYDROCHLORIDE
• Active Ingredient Strength: 1 g/1
• 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: 2022-12-31

Packaging

NDC 0173-0565-04

30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)

• Marketing Start Date: 2002-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0565-03 [00173056503]

VALTREX TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020487
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-30
• Marketing End Date: 2011-10-18

NDC 0173-0565-10 [00173056510]

VALTREX TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020487
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-08-12

NDC 0173-0565-04 [00173056504]

VALTREX TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020487
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-08-12

Drug Details

Active Ingredients

Ingredient	Strength
VALACYCLOVIR HYDROCHLORIDE	1 g/1

OpenFDA Data

• SPL SET ID: f8e0d8f8-cb73-4206-a484-88f5c4fbd719
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • G447S0T1VC
• RxNorm Concept Unique ID - RxCUI:
  • 108780
  • 212448
  • 313564
  • 313565
• UPC Code:
  • 0301730933089
  • 0301730565044

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 "VALTREX" or generic name "Valacyclovir Hydrochloride"

NDC	Brand Name	Generic Name
0173-0565	VALTREX	valacyclovir hydrochloride
0173-0933	VALTREX	valacyclovir hydrochloride
50090-0753	VALTREX	VALTREX
55289-926	VALTREX	VALTREX
63629-3982	VALTREX	VALTREX
70518-2039	VALTREX	VALTREX
67296-0200	VALTREX	VALTREX
0378-4275	Valacyclovir Hydrochloride	valacyclovir hydrochloride
0378-4276	Valacyclovir Hydrochloride	valacyclovir hydrochloride
0781-5208	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
0781-5209	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
0904-6565	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
10544-937	valacyclovir hydrochloride	valacyclovir hydrochloride
16714-697	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
16714-698	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
21695-832	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
21695-965	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride
43063-200	Valacyclovir Hydrochloride	Valacyclovir Hydrochloride