Home NDC 21695-832 Valacyclovir Hydrochloride
Product NDC 21695-832
11-digit product format 216950832
Labeler code 21695
Product ID 21695-832_796cf6ad-d86a-4c4e-9372-0eb649d3530d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA077135
Marketing category ANDA
Marketing start 2009-12-03
Marketing end 0000-00-00
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 21695-832-10 Valacyclovir Hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 2 21695-832-30 Valacyclovir Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 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 [REBEL DISTRIBUTORS CORP] 2 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-832 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 Legacy NDC, 2 package rows 20120223_6b2db776-4f30-4a17-a250-79654b86eca0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-832-10 21695083210 10 in 1 BOTTLE Historical 21695-832-30 21695083230 30 in 1 BOTTLE Historical