FDA.reportPublic FDA data

NDC 80777-112-01 - Spikevax

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
80777-112
Requested NDC
80777-112-01
Package NDCs from labels
80777-112-01, 80777-112-96, 80777-112-93, 80777-112-88
Manufacturer
Moderna US, Inc. | ModernaTX, Inc. | Rovi Pharma Industrial Services S.A. | Catalent Anagni S.R.L. | MODERNA BIOTECH SPAIN SL. | Associates of Cape Cod | Eurofins Lancaster Laboratories, LLC | Eurofins Biopharma Product Testing Ireland Limited
Effective date
2026-08-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SpikevaxModerna US, Inc. | ModernaTX, Inc. | Rovi Pharma Industrial Services S.A. | Catalent Anagni S.R.L. | MODERNA BIOTECH SPAIN SL. | Associates of Cape Cod | Eurofins Lancaster Laboratories, LLC | Eurofins Biopharma Product Testing Ireland Limited2026-08-17VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80777-112-01Spikevax0.5 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION0.510
80777-112-88Spikevax2 in 1 CARTONINJECTION, SUSPENSION210
80777-112-93Spikevax10 in 1 CARTONINJECTION, SUSPENSION1010
80777-112-96Spikevax10 in 1 CARTONINJECTION, SUSPENSION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80777-112-01ML - Milliliter80777-112df2ce925-99aa-4606-a118-2faf9b75ac6a12025-09-12
80777-112-88ML - Milliliter80777-1124c2bfb43-9b9f-473f-8e99-9943686f3f9b12025-09-12
80777-112-96ML - Milliliter80777-112d6f4b399-1735-4f85-becf-c0ab9edfb47412025-09-12

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 7 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hormone BalanceACETALDEHYDE, DOPAMINE HYDROCHLORIDE, DHEA (DEHYDROEPIANDROSTERONE), 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, FOLLICULINUM, OOPHORINUM (SUIS), CHOLESTERINUM, PROGESTERONE, TESTOSTERONE, CORTISONE ACETICUM, ALDOSTERONE, ANDROSTERONE, FOLLICLE STIMULATING HORMONEDr. Donna Restivo DC421707d6-31c1-4d57-b017-796fc872efe42025-05-23WarningsExact identifier
unii: 97C5T2UQ7J
HepastatBETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, FEL TAURI, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.d75ab44f-49cb-4a90-9e92-42457c6033192025-05-19WarningsExact identifier
unii: 97C5T2UQ7J
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACID OTICSaptalis Pharmaceuticals, LLCd9a3597c-2c9d-46cc-818b-8bb3aa5c4f322025-04-25Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Acetic AcidACETIC ACIDNuCare Pharmaceuticals,Inc.f9b4d18b-25f3-604f-e053-6394a90a55312025-02-10Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Endopan HPACETICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, BRYONIA (ALBA), CHROMIUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, SYZYGIUM JAMBOLANUM, THUJA OCCIDENTALIS, URANIUM NITRICUMEnergique, Inc.2bc69a24-c24c-4d12-92bb-7c073edf90dc2025-01-24WarningsExact identifier
unii: Q40Q9N063P
Bestmade Natural Products BM3BERB. VULGD3, CARDUUS MD2, CHELIDONIUMD2, CHOLESTRINUMD3, HYDRASTISD3, PTELEAD3Bestmade Natural Productseb65fa7a-1267-dc4f-e053-2995a90ae64f2025-01-22WarningsExact identifier
unii: 97C5T2UQ7J
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea04916-78e5-4651-e063-6394a90ac4be2025-01-16Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
D-138GARLIC, VISCUM ALBUM FRUITING TOP, OLEA EUROPAEA FLOWER BUD, PRUNUS DULCIS FLOWER, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, POTASSIUM IODIDE, AND CHOLESTEROLDNA Labs, Inc.3f17a0a3-7eff-477a-a21f-fc3f94f0a8ec2025-01-13WarningsExact identifier
unii: 97C5T2UQ7J
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2b9456-8ca0-8253-e053-2a95a90a8f122025-01-09Exact identifier
unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

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