Spikevax

Product NDC: 80777-100
Requested package NDC: 80777-100-99
11-digit product format: 807770100
Labeler code: 80777
Product ID: 80777-100_8483facf-1d72-4de3-ac81-eedc517bac1b
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: 2022-04-01
Marketing end: 0000-00-00
Substance: ELASOMERAN
Active strength: 0 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80777-100	80777-100-99	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80777-100-11	ML - Milliliter	80777-100	bba0658f-4fd5-4f30-8c36-f61c0c04e9d5	1	2022-06-06
80777-100-98	ML - Milliliter	80777-100	faed24d3-0d4b-48a3-a000-d9e441595ed2	1	2022-06-06
80777-100-99	ML - Milliliter	80777-100	6e2597a9-ebfe-43f4-b280-8f783ef548eb	1	2022-06-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80777-100-99	80777010099	10 VIAL in 1 CARTON (80777-100-99) > 5.5 mL in 1 VIAL (80777-100-11)	10 vial	2022-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spikevax	Moderna US, Inc. \| ModernaTX, Inc. \| Lonza Biologics, Inc. \| Catalent Indiana, LLC \| Baxter Pharmaceutical Solutions, LLC	2023-05-11	VACCINE LABEL	3