FDA.reportPublic FDA data

BIVIGAM

Product NDC
69800-6503
11-digit product format
698006503
Labeler code
69800
Product ID
69800-6503_3469d327-8d5d-fff5-e063-6394a90a2cf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Immune Globulin Intravenous (Human) 10%
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ADMA Biologics, Inc.
Application
BLA125389
Marketing category
BLA
Marketing start
2013-01-21
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
10 g/100mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BIVIGAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii66Y330CJHS
Rxcui1809414, 1809416, 1809421, 1809422

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809422Bivigam 10 % in 100 ML InjectionPSNa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809416Bivigam 10 % in 50 ML InjectionPSNa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSNa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSNa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809422100 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam]SBDa2244aa0-a6d0-11df-b385-0002a5d5c51b15
180941650 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam]SBDa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCDa2244aa0-a6d0-11df-b385-0002a5d5c51b15
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCDa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809422100 ML Bivigam 100 MG/ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
180941650 ML Bivigam 100 MG/ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809422Bivigam 10 % per 100 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809416Bivigam 10 % per 50 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809422Bivigam 10 GM per 100 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809416Bivigam 5 GM per 50 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809421immunoglobulin G, human 10 % per 100 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809414immunoglobulin G, human 10 % per 50 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSYa2244aa0-a6d0-11df-b385-0002a5d5c51b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69800-6503-1698006503011 VIAL, SINGLE-USE in 1 CARTON (69800-6503-1) / 100 mL in 1 VIAL, SINGLE-USE (69800-6503-2) 2013-01-210000-00-00NoNoCurrent
69800-6503-269800650302100 mL in 1 VIAL, SINGLE-USE100 mlHistorical