Home NDC 53808-0635 Valacyclovir Hydrochloride
Product NDC 53808-0635
11-digit product format 538080635
Labeler code 53808
Product ID 53808-0635_2d482302-2476-4395-bcc2-53404748c889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA077655
Marketing category ANDA
Marketing start 2013-01-01
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 53808-0635-1 Valacyclovir Hydrochloride 30 in 1 BLISTER PACK TABLET, FILM COATED 30 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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0635 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20140415_bdd38bb5-ff30-4392-a151-5234b9342304.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0635-1 53808063501 30 in 1 BLISTER PACK Historical