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 | Type |
|---|---|---|---|
| Spikevax | 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 | 2026-08-17 | VACCINE LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80777-112-01 | Spikevax | 0.5 mL in 1 SYRINGE, PLASTIC | INJECTION, SUSPENSION | 0.5 | 10 | |
| 80777-112-88 | Spikevax | 2 in 1 CARTON | INJECTION, SUSPENSION | 2 | 10 | |
| 80777-112-93 | Spikevax | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 10 | |
| 80777-112-96 | Spikevax | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80777-112-01 | ML - Milliliter | 80777-112 | df2ce925-99aa-4606-a118-2faf9b75ac6a | 1 | 2025-09-12 |
| 80777-112-88 | ML - Milliliter | 80777-112 | 4c2bfb43-9b9f-473f-8e99-9943686f3f9b | 1 | 2025-09-12 |
| 80777-112-96 | ML - Milliliter | 80777-112 | d6f4b399-1735-4f85-becf-c0ab9edfb474 | 1 | 2025-09-12 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 99b1cb12-0b2d-0c0f-e053-2a95a90ac3b6 | 2025-01-08 | Warnings, Adverse reactions | 059QF0KO0R |
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | a480e5f4-5f9e-4b23-b257-b0ac1ebfc115 | 2025-01-07 | Warnings | Q40Q9N063P |
| Acetic Acid | ACETIC ACID | TruPharma, LLC | 0c5ebd59-0e98-4ea1-b279-9202a19f6dbf | 2024-12-27 | Warnings, Adverse reactions | Q40Q9N063P |
| Gut Brain Spectrum | ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM | Energique, Inc. | adfee6ce-05b0-4955-bf5f-9612b8db4c78 | 2024-12-26 | Warnings | C151H8M554 |
| TROMETHAMINE | TROMETHAMINE | B. Braun Medical Inc. | 57db5686-7f7f-4999-87e3-e1cbbda4a98d | 2024-12-23 | Warnings, Adverse reactions | 023C2WHX2V |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| Focus | ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM | Deseret Biologicals, Inc. | e014e6b6-a07a-4170-b9af-f477da71597d | 2024-11-13 | Warnings | C151H8M554 |
| Plasma-Lyte 148 (pH 7.4) | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | fe935c8d-f42d-42e4-8665-0dc66829f231 | 2024-11-08 | 4550K0SC9B | |
| Crane Safety Eye Wash | WATER SOLUTION | Crane Safety LLC | 96d8dda9-6cd6-3f68-e053-2995a90a0da2 | 2024-11-08 | Warnings | 059QF0KO0R |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | 059QF0KO0R |
| Lactistat | ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALE | Energique, Inc. | 8dcc4a3a-9f21-4a77-ae42-b2c8283a076a | 2024-10-28 | Warnings | C151H8M554 |
| Grain and Seed Antigens | BAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | Energique, Inc. | a028eaea-76ef-45db-80e1-d7b4a0655d5e | 2024-10-25 | Warnings | C151H8M554 |
| Circulapar | CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUS | Energique, Inc. | 5bc2bcd0-5687-462a-8701-37c904a2e2d0 | 2024-10-24 | Warnings | 97C5T2UQ7J |
| Endopan HP | ACETICUM ACIDUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUM | Energique, Inc. | 0d475595-7afe-423f-9da8-720f1513f956 | 2024-10-24 | Warnings | Q40Q9N063P |
| Dental Pain | ACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICA | Deseret Biologicals, Inc. | 3a117358-3c51-4870-9932-701ffe90e3f8 | 2024-10-23 | Warnings | Q40Q9N063P |
| Cholesterol | CHOLESTERINUM | Deseret Biologicals, Inc. | f37a57de-b8f8-4b44-9e8c-820979a617d0 | 2024-10-23 | Warnings | 97C5T2UQ7J |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.