Home NDC 55648-152 VALACYCLOVIR HYDROCHLORIDE
Product NDC 55648-152
11-digit product format 556480152
Labeler code 55648
Product ID 55648-152_88df95c2-5088-4980-9d78-2d1760033ba7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VALACYCLOVIR HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
Application ANDA090216
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 2019-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-152-01 VALACYCLOVIR HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 2 55648-152-03 VALACYCLOVIR HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 2 55648-152-04 VALACYCLOVIR HYDROCHLORIDE 500 in 1 BOTTLE TABLET, FILM COATED 500 2 55648-152-05 VALACYCLOVIR HYDROCHLORIDE 10 in 1 CARTON TABLET, FILM COATED 10 2 55648-152-05 VALACYCLOVIR HYDROCHLORIDE 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-152 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 5 package rows 20130403_a9e1d18e-ad45-4183-bd98-53c7e0b36556.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-152-01 55648015201 30 in 1 BOTTLE Historical 55648-152-03 55648015203 90 in 1 BOTTLE Historical 55648-152-04 55648015204 500 in 1 BOTTLE Historical 55648-152-05 55648015205 10 in 1 CARTON Historical