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		2026-10-05
excluded package	package	59730-6503	59730-6503-1	D	Discontinued by firm		2026-10-05

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…`

Reported adverse events (FAERS/openFDA)#

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

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

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

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