Spikevax

Product NDC: 80777-112
11-digit product format: 807770112
Labeler code: 80777
Product ID: 80777-112_112d8af9-0172-4129-a89f-c76f20b366a7
Type: VACCINE
Nonproprietary name: COVID-19 Vaccine, mRNA
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Moderna US, Inc.
Application: BLA125752
Marketing category: BLA
Marketing start: 2025-08-27
Substance: CX-051869
Active strength: 50 ug/.5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80777-112		D	Discontinued by firm	2026-09-14
excluded package	package	80777-112	80777-112-88	D	Discontinued by firm	2026-09-14
excluded package	package	80777-112	80777-112-93	D	Discontinued by firm	2026-09-14
excluded package	package	80777-112	80777-112-96	D	Discontinued by firm	2026-09-14

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 table
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125752	Spikevax	COVID-19 Vaccine, mRNA	351(a)	Disc	2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2691172	SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.25 ML Prefilled Syringe, 6m through 11y	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691175	SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.5 ML Prefilled Syringe, 12y+	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722428	SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.25 ML Prefilled Syringe, 6m through 11y	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722437	SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2719760	spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691181	spikevax 2024-2025 vaccine, 0.5 ML Prefilled Syringe, 12y+	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722435	spikevax 2025-2026 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722438	spikevax 2025-2026 vaccine, 0.5 ML Prefilled Syringe, 12y+	PSN	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2719760	0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe [Spikevax 2024-2025]	SBD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722435	0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe [Spikevax 2025-2026]	SBD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691181	0.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe [Spikevax 2024-2025]	SBD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722438	0.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe [Spikevax 2025-2026]	SBD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691172	0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe	SCD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722428	0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe	SCD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691175	0.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe	SCD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722437	0.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled Syringe	SCD	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2719760	0.25 ML Spikevax 2024-2025 0.1 MG/ML Prefilled Syringe	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722435	0.25 ML Spikevax 2025-2026 0.1 MG/ML Prefilled Syringe	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722438	0.5 ML Spikevax 2025-2026 0.1 MG/ML Prefilled Syringe	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691172	SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.25 ML Prefilled Syringe, 6m through 11y	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691175	SARS-CoV-2 (COVID-19) vaccine 2024-2025, mRNA-1273 OMICRON (KP.2) 0.5 ML Prefilled Syringe, 12y+	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722428	SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.25 ML Prefilled Syringe, 6m through 11y	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722437	SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2719760	Spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2691181	Spikevax 2024-2025 vaccine, 0.5 ML Prefilled Syringe, 12y+	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722435	Spikevax 2025-2026 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10
2722438	Spikevax 2025-2026 vaccine, 0.5 ML Prefilled Syringe, 12y+	SY	f96b315c-fa57-4876-a7e5-a9b584d8e6e6	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80777-112-01	80777011201	0.5 mL in 1 SYRINGE, PLASTIC	0.5 ml				Historical
80777-112-88	80777011288	2 SYRINGE, PLASTIC in 1 CARTON (80777-112-88) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01)		2025-08-27	No	No	Historical
80777-112-93	80777011293	10 SYRINGE, PLASTIC in 1 CARTON (80777-112-93) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01)		2025-08-27	No	No	Historical
80777-112-96	80777011296	10 SYRINGE, PLASTIC in 1 CARTON (80777-112-96) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01)		2025-08-27	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
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	11