FDA.reportPublic FDA data

NDC 80777-345-01 - mRESVIA

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
80777-345
Requested NDC
80777-345-01
Package NDCs from labels
80777-345-01, 80777-345-90, 80777-345-96, 80777-345-89, 80777-345-62, 80777-345-63, 80777-345-61
Manufacturer
Moderna US, INC. | ModernaTX, Inc.
Effective date
2026-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
mRESVIA - Moderna US, INC. | ModernaTX, Inc.Moderna US, INC. | ModernaTX, Inc.2026-08-07VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80777-345-01mRESVIA0.5 mL in 1 SYRINGESUSPENSION0.55
80777-345-61mRESVIA10 in 1 CARTONSUSPENSION105
80777-345-62mRESVIA1 in 1 CARTONSUSPENSION15
80777-345-63mRESVIA2 in 1 CARTONSUSPENSION25
80777-345-89mRESVIA2 in 1 CARTONSUSPENSION25
80777-345-90mRESVIA1 in 1 CARTONSUSPENSION15
80777-345-96mRESVIA10 in 1 CARTONSUSPENSION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80777-345MRESVIA (RESPIRATORY SYNCYTIAL VIRUS VACCINE) SUSPENSION [MODERNA US, INC.]4Current NDC, 7 package rows20241226_e5c837e7-41e8-496a-9c85-6b0453b35948.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80777-345-01ML - Milliliter80777-345639c9de3-5187-4b1d-be42-2a6600e8468a12024-07-12
80777-345-61ML - Milliliter80777-345c4159982-34cb-4954-9d0c-44d72e764a2912025-09-12
80777-345-63ML - Milliliter80777-3451c997840-0d97-407f-bc70-517756e43a5c12025-09-12
80777-345-90ML - Milliliter80777-3457b14b36b-f28d-4ca3-bc22-d87db62aa2fd12024-07-12
80777-345-96ML - Milliliter80777-34594df3056-82b3-4035-9eee-12e64c1fb91712024-07-12

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 3 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
HepastatBETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, CHOLINUM, FEL TAURI, CALCAREA CARBONICA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.d9ceea3f-c270-40fa-bf16-d83c683005ac2026-03-06WarningsExact identifier
unii: 97C5T2UQ7J
Upper Gi and Enzyme RestorationACETICUM ACIDUM, AGARICUS MUSCARIUS, ALOE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINCHONA OFFICINALIS, GRAPHITES, IPECACUANHA, LAC DEFLORATUM, MENTHA PIPERITA, NUX VOMICA, SECALE CORNUTUM, TANACETUM VULGARE, TEUCRIUM MARUM AND ZINGIBER OFFICINALE.King Bio Inc.84e268e5-ba68-4ad6-84d4-d799c4ea91ee2026-03-04WarningsExact identifier
unii: Q40Q9N063P
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: Q40Q9N063P
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.91e8e37c-c654-6df9-e053-2995a90aafe12026-01-29WarningsExact identifier
unii: 97C5T2UQ7J
FUNGAL NAIL TREATMENTFUNGAL NAIL TREATMENTJiangxi He-Oumei Health Industry Co., Ltd.4922f627-167a-1783-e063-6394a90acd6f2026-01-24WarningsExact identifier
unii: Q40Q9N063P
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 97C5T2UQ7J
Gallbladder Drops 5006GALLBLADDER DROPSProfessional Complementary Health Formulasf07b10e1-00b1-47d7-b745-72165781c6d22026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
POP Detox 6045POP DETOXProfessional Complementary Health Formulas48e7e23a-014c-4259-a2c9-37127da3ba032026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
Hyperhidrosis Drops 2144HYPERHIDROSIS DROPSProfessional Complementary Health Formulasbca49d5e-6ade-41d5-82f5-1551936d0a3b2026-01-08WarningsExact identifier
unii: Q40Q9N063P
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Blood Clenz Drops 2012BLOOD CLENZ DROPSProfessional Complementary Health Formulas80a273da-bce5-4e37-89da-f40db0491e622026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
Cholesterol 1551CHOLESTEROLProfessional Complementary Health Formulasc8f91020-5840-4e8f-a7ab-867c7e11fb632026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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