FDA.reportPublic FDA data

NDC 69800-6503-02 - BIVIGAM

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
69800-6503
Requested NDC
69800-6503-02
Package NDCs from labels
69800-6503-2, 69800-6503-1, 69800-6503-02
Manufacturer
ADMA Biologics, Inc.
Effective date
2026-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BIVIGAM - ADMA Biologics, Inc.ADMA Biologics, Inc.2026-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69800-6503-1BIVIGAM1 in 1 CARTONINJECTION, SOLUTION115
69800-6503-2BIVIGAM100 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69800-6503BIVIGAM (IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%) INJECTION, SOLUTION [ADMA BIOLOGICS, INC.]15Current NDC, Legacy NDC, 2 package rows20250507_a2244aa0-a6d0-11df-b385-0002a5d5c51b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69800-6503-1ML - Milliliter69800-65035387ecb8-c0af-4240-9a1d-82e17815ec5012021-09-07
69800-6503-2ML - Milliliter69800-6503cea45d7d-27ae-4856-8ae5-523e0f8d60bf12021-09-07

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
application number: BLA125389
ndc (package): 69800-6503-2
ndc (package): 69800-6502-1
ndc (package): 69800-6503-1
ndc (package): 69800-6502-2
ndc (product): 69800-6502
ndc (product): 69800-6503
ndc11 (package): 69800650302
rxcui: 1809422
rxcui: 1809416
rxcui: 1809421
rxcui: 1809414
spl id: 3469d327-8d5d-fff5-e063-6394a90a2cf2
spl set id: a2244aa0-a6d0-11df-b385-0002a5d5c51b
unii: 66Y330CJHS

Reported adverse events (FAERS/openFDA)#

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