Home NDC 75921-208 VALACYCLOVIR HYDROCHLORIDE
Product NDC 75921-208
11-digit product format 759210208
Labeler code 75921
Product ID 75921-208_396aa302-3785-46a0-8369-256f458ebcd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VALACYCLOVIR HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler Life Line Home Care Services, Inc.
Application ANDA077478
Marketing category ANDA
Marketing start 2010-05-24
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 75921-208-03 VALACYCLOVIR HYDROCHLORIDE 3 in 1 BOTTLE TABLET, COATED 3 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75921-208 VALACYCLOVIR HYDROCHLORIDE TABLET, COATED [LIFE LINE HOME CARE SERVICES, INC.] 1 Legacy NDC, 1 package rows 20120326_b0e6fa63-7b34-4453-a259-34ffd917f4d7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 75921-208-03 75921020803 3 in 1 BOTTLE Historical