FDA.reportPublic FDA data

NDC 55111-552-79 - 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
55111-552
Requested NDC
55111-552-79
Package NDCs from labels
55111-552-30, 55111-552-42, 55111-552-90, 55111-552-05, 55111-552-79, 55111-552-78
Manufacturer
Dr. Reddys Laboratories Limited | Dr. Reddys Laboratories Limited-FTO 3
Effective date
2018-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valacyclovir Hydrochloride - Dr. Reddys Laboratories Limited | Dr. Reddys Laboratories Limited-FTO 3Dr. Reddys Laboratories Limited | Dr. Reddys Laboratories Limited-FTO 32018-12-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
55111-552-05These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-552-30These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-552-42These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-552-78These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995
55111-552-90These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-552-05Valacyclovir Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011
55111-552-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
55111-552-42Valacyclovir Hydrochloride42 in 1 BOTTLETABLET, FILM COATED4211
55111-552-78Valacyclovir Hydrochloride10 in 1 CARTONTABLET, FILM COATED1011
55111-552-79Valacyclovir Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1011
55111-552-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-552VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]11Legacy NDC, 6 package rows20190312_2d38cbdb-4e4d-4174-461d-7a3b6475e6a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-552-05EA - Each55111-552cc8f254a-1c14-494f-9e58-16805bd2223e12012-07-24
55111-552-30EA - Each55111-552236f9372-f594-4e6f-ab29-e038f330688712012-07-24
55111-552-90EA - Each55111-5525560117a-f9be-41ab-894a-e61f1f1f2ed412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
valacyclovirACTIVE INGREDIENTMZ1IW7Q79DVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
valacyclovirACTIVE MOIETYMZ1IW7Q79DVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
carnauba waxINACTIVE INGREDIENTR12CBM0EIZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]7

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
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
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: 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
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Valacyclovir HydrochlorideVALACYCLOVIR HYDROCHLORIDEREMEDYREPACK INC.740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f2026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 313565
unii: G447S0T1VC

Reported adverse events (FAERS/openFDA)#

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