Home NDC 51079-093 Valacyclovir Hydrochloride
Product NDC 51079-093
11-digit product format 510790093
Labeler code 51079
Product ID 51079-093_3a876b4d-bba8-c8d4-e063-6394a90abaa0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA078518
Marketing category ANDA
Marketing start 2011-03-07
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 313565
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51079-093-01 Valacyclovir Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 10 51079-093-03 Valacyclovir Hydrochloride 30 in 1 CARTON TABLET, FILM COATED 30 10
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 [MYLAN INSTITUTIONAL INC.] 3 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-093 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 9 Current NDC, Legacy NDC, 2 package rows 20241012_2f0ecd75-e4b4-4493-b7a4-1666fc555c70.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 51079-093-01 51079009301 1 in 1 BLISTER PACK Historical 51079-093-03 51079009303 30 BLISTER PACK in 1 CARTON (51079-093-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-093-01) 30 blister pack 2011-03-07 0000-00-00 No No Current