FDA.reportPublic FDA data

BIVIGAM

Product NDC
59730-6503
Requested package NDC
59730-6503-1
11-digit product format
597306503
Labeler code
59730
Product ID
59730-6503_98e27c22-044d-e814-e053-2a95a90a961b
Type
PLASMA DERIVATIVE
Nonproprietary name
HUMAN IMMUNOGLOBULIN G
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ADMA Biologics, Inc
Application
BLA125389
Marketing category
BLA
Marketing start
2013-02-04
Marketing end
2021-09-30
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
10 g/100mL
Pharmacologic classes
Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59730-650359730-6503-1DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIVIGAMIMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%ADMA Biologics, Inc.a2244aa0-a6d0-11df-b385-0002a5d5c51b2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125389

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59730-6503-1ML - Milliliter59730-6503af4abfc5-9ca7-4b94-8170-c649b1d16e4b12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSBIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]7
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSBIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]7
GLYCINEINACTIVE INGREDIENTTE7660XO1CBIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]7
WATERINACTIVE INGREDIENT059QF0KO0RBIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]7

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125389BivigamImmune Globulin Intravenous (Human)351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59730-6503-159730650301100 mL in 1 VIAL, GLASS (59730-6503-1) 100 ml2013-02-042021-09-30NoNoCurrent