Home NDC 68084-215 Valacyclovir Hydrochloride
Product NDC 68084-215
11-digit product format 680840215
Labeler code 68084
Product ID 68084-215_2b33f10e-86de-a58f-e063-6294a90ae7ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA090682
Marketing category ANDA
Marketing start 2014-08-20
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Valacyclovir Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 500 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii G447S0T1VC Rxcui 313564, 313565
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68084-215-01 Valacyclovir Hydrochloride 100 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 100 9 68084-215-11 Valacyclovir Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 9 68084-215-21 Valacyclovir Hydrochloride 30 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 30 9
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 [AMERICAN HEALTH PACKAGING] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-215 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 9 Current NDC, Legacy NDC, 3 package rows 20250110_23fb4162-2310-486c-ba9f-f7c94b793e56.zip
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 68084-215-01 68084021501 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-215-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-215-11) 100 blister pack 2014-08-20 0000-00-00 No No Current 68084-215-11 68084021511 1 in 1 BLISTER PACK Historical 68084-215-21 68084021521 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-215-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-215-11) 30 blister pack 2021-07-28 0000-00-00 No No Current