BIVIGAM

Product NDC: 59730-6503
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59730-6503		D	Discontinued by firm		2026-08-17
excluded package	package	59730-6503	59730-6503-1	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59730-6503-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59730-6503-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59730-6503-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59730-6503-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59730-6503-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59730-6503-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59730-6503-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59730-6503-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59730-6503-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59730-6503-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59730-6503-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59730-6503-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59730-6503-1	ML - Milliliter	59730-6503	af4abfc5-9ca7-4b94-8170-c649b1d16e4b	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN IMMUNOGLOBULIN G	ACTIVE INGREDIENT	66Y330CJHS	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]	7
HUMAN IMMUNOGLOBULIN G	ACTIVE MOIETY	66Y330CJHS	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]	7
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BIOTEST PHARMACEUTICALS CORPORATION]	7

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIVIGAM	IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%	ADMA Biologics, Inc.	a2244aa0-a6d0-11df-b385-0002a5d5c51b	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125389

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	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
66Y330CJHS	HUMAN IMMUNOGLOBULIN G	308067-58-5	HUMAN IMMUNOGLOBULIN G

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59730-6503-1	59730650301	100 mL in 1 VIAL, GLASS (59730-6503-1)	100 ml	2013-02-04	2021-09-30	No	No	Current