Home NDC 0378-4275 Valacyclovir Hydrochloride
Product NDC 0378-4275
11-digit product format 003784275
Labeler code 0378
Product ID 0378-4275_7de6158d-06ad-4500-a485-dafc151c16ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA078518
Marketing category ANDA
Marketing start 2010-05-24
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 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 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 0378-4275-77 Valacyclovir Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 19 0378-4275-93 Valacyclovir Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 19
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 PHARMACEUTICALS INC.] 8 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 AMMONIA INACTIVE INGREDIENT 5138Q19F1X VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 SHELLAC INACTIVE INGREDIENT 46N107B71O VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 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 0378-4275 VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 17 Current NDC, Legacy NDC, 2 package rows 20240123_56bf715d-8280-4557-9f98-9693932199e5.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 0378-4275-77 00378427577 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77) 2010-05-24 0000-00-00 No No Current 0378-4275-93 00378427593 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93) 2010-05-24 0000-00-00 No No Current