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 1 of 115 · 2,293 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
ValacyclovirVALACYCLOVIRSportpharm LLC14e479b1-8afd-4912-8f93-59b60a0868bc2026-09-05Warnings, Adverse reactionsExact identifier
rxcui: 313564
rxcui: 313565
unii: G447S0T1VC
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
ValacyclovirVALACYCLOVIRPD-Rx Pharmaceuticals, Inc.f30b9f67-0c2e-45c2-a480-07eddee0d2db2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 313564
unii: G447S0T1VC
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
ValacyclovirVALACYCLOVIRAphena Pharma Solutions - Tennessee, LLC59e104dd-6356-e323-e063-6394a90a63962026-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA076588
rxcui: 313565
unii: G447S0T1VC
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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