Home NDC 52343-051 Valacyclovir
Product NDC 52343-051
11-digit product format 523430051
Labeler code 52343
Product ID 52343-051_d6adb9f0-31da-4a25-aaaf-443f16660755
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ACETRIS HEALTH, LLC
Application ANDA090682
Marketing category ANDA
Marketing start 2010-05-24
Marketing end 0000-00-00
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic 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 No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52343-051-30 52343005130 30 TABLET, FILM COATED in 1 BOTTLE (52343-051-30) 2010-05-24 0000-00-00 No No Current 52343-051-90 52343005190 90 TABLET, FILM COATED in 1 BOTTLE (52343-051-90) 2010-05-24 0000-00-00 No No Current