Home NDC 69800-6503-1 BIVIGAM
Product NDC 69800-6503
Requested package NDC 69800-6503-1
11-digit product format 698006503
Labeler code 69800
Product ID 69800-6503_5c911b88-a905-773c-e063-6294a90ac2bd
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BIVIGAM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN IMMUNOGLOBULIN G 10 g/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69800-6503-1 BIVIGAM 1 in 1 CARTON INJECTION, SOLUTION 1 15 69800-6503-2 BIVIGAM 100 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69800-6503 BIVIGAM (IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%) INJECTION, SOLUTION [ADMA BIOLOGICS, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20250507_a2244aa0-a6d0-11df-b385-0002a5d5c51b.zip
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 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125389 Bivigam Immune Globulin Intravenous (Human) 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1809422 Bivigam 10 % in 100 ML Injection PSN a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809416 Bivigam 10 % in 50 ML Injection PSN a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809421 immunoglobulin G, human 10 % in 100 ML Injection PSN a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809414 immunoglobulin G, human 10 % in 50 ML Injection PSN a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809422 100 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam] SBD a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809416 50 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam] SBD a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809421 100 ML immunoglobulin G, human 100 MG/ML Injection SCD a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809414 50 ML immunoglobulin G, human 100 MG/ML Injection SCD a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809422 100 ML Bivigam 100 MG/ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809416 50 ML Bivigam 100 MG/ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809422 Bivigam 10 % per 100 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809416 Bivigam 10 % per 50 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809422 Bivigam 10 GM per 100 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809416 Bivigam 5 GM per 50 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809421 immunoglobulin G, human 10 % per 100 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809414 immunoglobulin G, human 10 % per 50 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809421 immunoglobulin G, human 10 GM per 100 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15 1809414 immunoglobulin G, human 5 GM per 50 ML Injection SY a2244aa0-a6d0-11df-b385-0002a5d5c51b 15
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69800-6503-1 69800650301 1 VIAL, SINGLE-USE in 1 CARTON (69800-6503-1) / 100 mL in 1 VIAL, SINGLE-USE (69800-6503-2) 2013-01-21 0000-00-00 No No Current