Home NDC 16714-697 Valacyclovir Hydrochloride
Product NDC 16714-697
11-digit product format 167140697
Labeler code 16714
Product ID 16714-697_6b2156c4-0d81-4c53-b497-85ed8d7656d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA090682
Marketing category ANDA
Marketing start 2010-05-24
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 1 g/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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Valacyclovir Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 1 g/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 16714-697-01 Valacyclovir Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 20 16714-697-02 Valacyclovir Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 20 16714-697-03 Valacyclovir Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 20 16714-697-04 Valacyclovir Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 20
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 [NORTHSTAR RX LLC] 6 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 6 VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 VALACYCLOVIR ACTIVE MOIETY MZ1IW7Q79D VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-697 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] 18 Current NDC, Legacy NDC, 4 package rows 20240110_4acf51de-26f7-42b2-8acc-61b800627ef3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-697-01 16714069701 30 TABLET, FILM COATED in 1 BOTTLE (16714-697-01) 2010-05-24 0000-00-00 No No Current 16714-697-02 16714069702 100 TABLET, FILM COATED in 1 BOTTLE (16714-697-02) 2010-05-24 0000-00-00 No No Current 16714-697-03 16714069703 90 TABLET, FILM COATED in 1 BOTTLE (16714-697-03) 2010-05-24 0000-00-00 No No Current 16714-697-04 16714069704 500 in 1 BOTTLE Historical