Pfizer-BioNTech Covid-19 Vaccine, Bivalent

Product NDC: 59267-1404
Requested package NDC: 59267-1404-2
11-digit product format: 592671404
Labeler code: 59267
Product ID: 59267-1404_6eb1716c-3f57-4dc4-8c81-caa880161443
Type: VACCINE
Nonproprietary name: BNT162b2 Original and Omicron BA.4/BA.5
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Pfizer Manufacturing Belgium NV
Marketing category: EMERGENCY USE AUTHORIZATION
Marketing start: 2022-09-01
Marketing end: 0000-00-00
Substance: FAMTOZINAMERAN; TOZINAMERAN
Active strength: 0 mg/.48mL; mg/.48mL
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	59267-1404	59267-1404-2	D	Discontinued by firm		2026-10-12

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
59267-1404-1	ML - Milliliter	59267-1404	c44731fd-e7ed-4df3-9402-240cca4b7137	1	2022-09-12
59267-1404-2	ML - Milliliter	59267-1404	212abd14-be73-4f86-9ce1-79c1b42da482	1	2022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59267-1404-2	59267140402	10 VIAL, GLASS in 1 CARTON (59267-1404-2) > .48 mL in 1 VIAL, GLASS (59267-1404-1)	2022-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT	Pfizer Manufacturing Belgium NV \| Pfizer Inc \| Pharmacia & Upjohn Company LLC \| BioNTech Innovative Manufacturing Services GmbH \| BioNTech Manufacturing GmbH \| BioNTech Manufacturing Marburg GmbH \| Hospira, Inc. \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals	2022-12-12	VACCINE LABEL	5