Home NDC 0781-5208 Valacyclovir Hydrochloride
Product NDC 0781-5208
11-digit product format 007815208
Labeler code 0781
Product ID 0781-5208_7ad950ff-aaff-4da0-b1ae-403d86fb06a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sandoz 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 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 2022-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# 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 RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-5208-01 00781520801 100 TABLET in 1 BOTTLE (0781-5208-01) 100 tablet 2010-05-24 0000-00-00 No No Current 0781-5208-05 00781520805 500 TABLET in 1 BOTTLE (0781-5208-05) 500 tablet 2010-05-24 0000-00-00 No No Current 0781-5208-13 00781520813 100 TABLET in 1 BOX, UNIT-DOSE (0781-5208-13) 100 tablet 2010-05-24 0000-00-00 No No Current 0781-5208-31 00781520831 30 TABLET in 1 BOTTLE (0781-5208-31) 30 tablet 2010-05-24 0000-00-00 No No Current 0781-5208-92 00781520892 90 TABLET in 1 BOTTLE (0781-5208-92) 90 tablet 2010-05-24 0000-00-00 No No Current