NDC 0069-8400-01 - Octagam Immune Globulin (Human)

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: 0069-8400
Requested NDC: 0069-8400-01
Package NDCs from labels: 0069-8400-01, 0069-8400-02
Manufacturer: Pfizer Laboratories Div Pfizer Inc
Effective date: 2024-01-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Octagam Immune Globulin (Human) - Pfizer Laboratories Div Pfizer Inc	Pfizer Laboratories Div Pfizer Inc	2024-01-29	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-8400-01	Octagam Immune Globulin (Human)	20 mL in 1 BOTTLE, GLASS	SOLUTION	20		3
0069-8400-02	Octagam Immune Globulin (Human)	1 in 1 CARTON	SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-8400	OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	3	Current NDC, 2 package rows	20240130_fb07257b-e5e2-64c8-666c-65009f0aa604.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-8400-01	ML - Milliliter	0069-8400	946911ed-d466-4fcf-8ac1-6f1015e55d57	1	2023-12-05
0069-8400-02	ML - Milliliter	0069-8400	8914e790-b6b0-464e-81c4-96d055e40d88	1	2024-02-14

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASCENIV	HUMAN IMMUNOGLOBULIN G	ADMA Biologics, Inc.	d74f4360-3b51-496c-96fb-84c3976958d2	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 66Y330CJHS
QIVIGY kthm	HUMAN IMMUNOGLOBULIN G	Kedrion S.p.A.	6f1933e0-240f-48f4-b246-8a30e63a4160	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 66Y330CJHS
BIVIGAM	IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%	ADMA Biologics, Inc.	a2244aa0-a6d0-11df-b385-0002a5d5c51b	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 66Y330CJHS

Reported adverse events (FAERS/openFDA)#

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