FDA.reportPublic FDA data

NDC 50268-789-11 - 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
50268-789
Requested NDC
50268-789-11
Package NDCs from labels
50268-789-11, 50268-789-15
Manufacturer
AvPAK
Effective date
2025-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valacyclovir Hydrochloride - AvPAKAvPAK2025-10-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-789-11Valacyclovir Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17
50268-789-15Valacyclovir Hydrochloride50 in 1 BOX, UNIT-DOSETABLET, FILM COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-789VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]6Current NDC, Legacy NDC, 2 package rows20220507_7f5fc62f-d043-db36-ce92-7adc4f7a79a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-789-11EA - Each50268-789d43be261-24eb-4fb0-8a8b-8e2bf4ad663712014-12-01
50268-789-15EA - Each50268-78960180bef-83d3-46da-9bf7-eff7aebf15ff12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1

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 113 · 2,241 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
ValacyclovirVALACYCLOVIRSportpharm LLC14e479b1-8afd-4912-8f93-59b60a0868bc2026-09-05Warnings, Adverse reactionsExact identifier
rxcui: 313564
rxcui: 313565
unii: G447S0T1VC
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
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 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
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
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
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
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
application number: ANDA090682
rxcui: 313565
unii: G447S0T1VC

Reported adverse events (FAERS/openFDA)#

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