FDA.reportPublic FDA data

NDC 63304-905-11 - Valacyclovir

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
63304-905
Requested NDC
63304-905-11
Package NDCs from labels
63304-905-03, 63304-905-30, 63304-905-90, 63304-905-05, 63304-905-11, 63304-905-77
Manufacturer
Golden State Medical Supply, Inc.
Effective date
2026-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valacyclovir - Golden State Medical Supply, Inc.Golden State Medical Supply, Inc.2026-06-16HUMAN PRESCRIPTION DRUG LABEL
Valacyclovir - SUN PHARMACEUTICAL INDUSTRIES, INC. | Ohm Laboratories Inc.SUN PHARMACEUTICAL INDUSTRIES, INC. | Ohm Laboratories Inc.2026-06-04HUMAN PRESCRIPTION DRUG LABEL
Valacyclovir - REMEDYREPACK INC.REMEDYREPACK INC.2019-03-08HUMAN PRESCRIPTION DRUG LABEL
Valacyclovir - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2017-05-23HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63304-905-032020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-032020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-12-19These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-032020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-032020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-052020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-302020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-772020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
63304-905-902020-01-31These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-905-03Valacyclovir10 in 1 BOTTLETABLET, FILM COATED1018
63304-905-05Valacyclovir500 in 1 BOTTLETABLET, FILM COATED50018
63304-905-11Valacyclovir1 in 1 BLISTER PACKTABLET, FILM COATED118
63304-905-30Valacyclovir30 in 1 BOTTLETABLET, FILM COATED3018
63304-905-77Valacyclovir100 in 1 CARTONTABLET, FILM COATED10018
63304-905-90Valacyclovir90 in 1 BOTTLETABLET, FILM COATED9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-905VALACYCLOVIR TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]17Current NDC, Legacy NDC, 6 package rows20231130_26634bf1-c6d8-4d48-9a4e-845c47df07f8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-905-30EA - Each63304-905ea493b51-c70d-484d-94b6-aa3736a4cf2712012-07-24
63304-905-90EA - Each63304-905dfbae9e0-a985-4745-b57b-0676259de03712021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
POVIDONESINACTIVE INGREDIENTFZ989GH94EVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]12

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 113 · 2,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
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: 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
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: 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
ValacyclovirVALACYCLOVIRREMEDYREPACK INC.5e39bf80-ada6-4194-bf3d-2c044c3389da2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC
ValacyclovirVALACYCLOVIRREMEDYREPACK INC.7c332401-afb6-455b-b61a-ea108a377ef62026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC

Reported adverse events (FAERS/openFDA)#

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