FDA.reportPublic FDA data

NDC 0378-4276-05 - Valacyclovir Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0378-4276
Requested NDC
0378-4276-05
Package NDCs from labels
0378-4276-93, 0378-4276-77, 0378-4276-05
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valacyclovir Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-06-26HUMAN PRESCRIPTION DRUG LABEL
Valacyclovir Hydrochloride - Northwind Health Company, LLCNorthwind Health Company, LLC2026-06-24HUMAN PRESCRIPTION DRUG LABEL
Valacyclovir Hydrochloride - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2026-02-16HUMAN PRESCRIPTION DRUG LABEL
Valacyclovir Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2022-02-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4276-77Valacyclovir Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019
0378-4276-93Valacyclovir Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4276VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20240123_56bf715d-8280-4557-9f98-9693932199e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4276-05EA - Each0378-42762a4cffee-ee75-48c4-8174-71c7741cb4fc12012-07-24
0378-4276-77EA - Each0378-4276f2d9457c-df32-4615-937a-cb05ba319bd512012-07-24
0378-4276-93EA - Each0378-4276ec164c54-b5df-4745-8112-ab66a7da191112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 114 · 2,280 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
ValacyclovirVALACYCLOVIRSt. Mary's Medical Park Pharmacy5903c8eb-8538-adad-e063-6294a90a5fed2026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDECardinal Health 107, LLC72300f70-57fd-42a8-a2dc-4cf95a1ce8052026-08-13Warnings, Adverse reactionsExact identifier
rxcui: 313565
unii: G447S0T1VC
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.de96c14b-cd74-46dd-bcce-d1fa640a60372026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDERedpharm Drug57e5cc11-f3cb-6266-e063-6394a90afc472026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
ValacyclovirVALACYCLOVIRREMEDYREPACK INC.5e39bf80-ada6-4194-bf3d-2c044c3389da2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.