FDA.reportPublic FDA data

NDC 68084-965-95 - Valganciclovir

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
68084-965
Requested NDC
68084-965-95
Package NDCs from labels
68084-965-18, 68084-965-19, 68084-965-95, 68084-965-25
Manufacturer
American Health Packaging
Effective date
2026-06-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valganciclovir - American Health PackagingAmerican Health Packaging2026-06-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-965-18Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED17
68084-965-19Valganciclovir20 in 1 CARTONTABLET, FILM COATED207
68084-965-25Valganciclovir30 in 1 BOX, UNIT-DOSETABLET, FILM COATED307
68084-965-95Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-965VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 4 package rows20240925_4db6dd63-e56b-45a4-86b2-ee125a1854a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-965-18EA - Each68084-965f2ec7b19-7949-4bef-abbb-f5f57c5c181312024-10-04
68084-965-19EA - Each68084-96549fd3786-0775-40b3-9cd5-287b71e4c19812024-10-04
68084-965-25EA - Each68084-96513fa8694-1f0c-43fc-9e89-cdf4faf24a4712015-02-02
68084-965-95EA - Each68084-965c03a6ea6-bd94-46db-bbdf-1a5d80f729cd12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALGANCICLOVIR HYDROCHLORIDEACTIVE INGREDIENT4P3T9QF9NZVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
GanciclovirACTIVE MOIETYP9G3CKZ4P5VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
crospovidoneINACTIVE INGREDIENT68401960MKVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
magnesium stearateINACTIVE INGREDIENT70097M6I30VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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 4 of 111 · 2,217 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
ValganciclovirVALGANCICLOVIRAmerican Health Packaging4db6dd63-e56b-45a4-86b2-ee125a1854a02026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203511
ndc (package): 68084-965-19
ndc (package): 68084-965-95
ndc (package): 68084-965-18
ndc (package): 68084-965-25
ndc (product): 68084-965
ndc11 (package): 68084096595
rxcui: 313566
spl id: 55015e34-52fc-0309-e063-6394a90af0f9
spl set id: 4db6dd63-e56b-45a4-86b2-ee125a1854a0
unii: 4P3T9QF9NZ
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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