Home NDC 52959-303 Valacyclovir Hydrochloride
Product NDC 52959-303
11-digit product format 529590303
Labeler code 52959
Product ID 52959-303_dbcf8a7d-54ef-41ef-b7d6-7b0ad073a7b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA077135
Marketing category ANDA
Marketing start 2010-05-24
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 52959-303-21 Valacyclovir Hydrochloride 21 in 1 BOTTLE TABLET, FILM COATED 21 5
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 [H.J. HARKINS COMPANY, INC.] 5 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-303 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 5 Legacy NDC, 1 package rows 20120420_bcfc31a1-b604-4cd1-a9e0-681e60d4cd2e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-303-21 52959030321 21 in 1 BOTTLE Historical