Home NDC 21695-965 Valacyclovir Hydrochloride
Product NDC 21695-965
11-digit product format 216950965
Labeler code 21695
Product ID 21695-965_11d1e166-9577-47b0-a338-d11ab3ba44aa
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 2010-06-11
Marketing end 0000-00-00
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 1 g/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 21695-965-04 Valacyclovir Hydrochloride 4 in 1 BOTTLE TABLET, FILM COATED 4 1 21695-965-07 Valacyclovir Hydrochloride 7 in 1 BOTTLE TABLET, FILM COATED 7 1 21695-965-21 Valacyclovir Hydrochloride 21 in 1 BOTTLE TABLET, FILM COATED 21 1
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] 1 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-965 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 3 package rows 20111118_11d1e166-9577-47b0-a338-d11ab3ba44aa.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-965-04 21695096504 4 in 1 BOTTLE Historical 21695-965-07 21695096507 7 in 1 BOTTLE Historical 21695-965-21 21695096521 21 in 1 BOTTLE Historical