NDC 0069-1109-01 - Panzyga

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
0069-1109
Requested NDC
0069-1109-01
Package NDCs from labels
0069-1109-01, 0069-1109-02
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Effective date
2025-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Panzyga - Pfizer Laboratories Div Pfizer IncPfizer Laboratories Div Pfizer Inc2025-05-08PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1109-01Panzyga25 mL in 1 BOTTLE, GLASSSOLUTION2510
0069-1109-02Panzyga1 in 1 CARTONSOLUTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1109PANZYGA (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]9Current NDC, Legacy NDC, 2 package rows20250410_e2cc5ddf-119e-ade3-79c2-c712cfbee099.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1109-01ML - Milliliter0069-110967acfad5-d096-43f3-866d-f3d76383669b12019-09-05
0069-1109-02ML - Milliliter0069-11095f10f924-ffe1-49a5-8ea7-a7d20d7692bd12019-09-05

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 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASCENIVHUMAN IMMUNOGLOBULIN GADMA Biologics, Inc.d74f4360-3b51-496c-96fb-84c3976958d22026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 66Y330CJHS
QIVIGY kthmHUMAN IMMUNOGLOBULIN GKedrion S.p.A.6f1933e0-240f-48f4-b246-8a30e63a41602026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 66Y330CJHS
BIVIGAMIMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%ADMA Biologics, Inc.a2244aa0-a6d0-11df-b385-0002a5d5c51b2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 66Y330CJHS

Reported adverse events (FAERS/openFDA)#

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