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 4 of 18 · 347 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carduus Combination 9215CARDUUS COMBINATIONProfessional Complementary Health Formulasa244de13-836f-49b5-8c7a-d45bde704d782026-01-08WarningsExact identifier
unii: 97C5T2UQ7J
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: 043IPI2M0K
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 043IPI2M0K
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Pancreas Drops 5020PANCREAS DROPSProfessional Complementary Health Formulas669a47a1-ae68-4b49-9f21-288314e9eb762026-01-08WarningsExact identifier
unii: Q40Q9N063P
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea1466d-a492-4056-e063-6394a90a80bf2026-01-07Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
TromethamineTROMETHAMINEMILLA PHARMACEUTICALS INC.082b1104-502b-47af-95bf-0dbf2422990e2026-01-07Warnings, Adverse reactionsExact identifier
unii: 023C2WHX2V
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: Q40Q9N063P
CirculopathADENOSINUM CYCLOPHOSPHORICUM, ARNICA MONTANA, AURUM MURIATICUM, BARYTA MURIATICA, BORAGO OFFICINALIS, CHOLESTERINUM, CITRUS LIMONUM, HYPOTHALAMUS (BOVINE), KALI IODATUM, LAUROCERASUS, MAGNESIA MURIATICA, NADIDUM, PHASEOLUS, PHOSPHORUS, THYROIDINUM (BOVINE)Energetix Corporation448d5ea0-ca41-487a-8321-38b1667764bd2025-12-17WarningsExact identifier
unii: 97C5T2UQ7J
Brain SuppBRAIN SUPPORTVitality Works, Inc.4be3d5f8-f974-4ed6-ba90-f0ce08a600fe2025-12-17WarningsExact identifier
unii: 97C5T2UQ7J
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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