NABI-HB

Product NDC: 59730-4203
Requested package NDC: 59730-4203-1
11-digit product format: 597304203
Labeler code: 59730
Product ID: 59730-4203_98e263d9-a5c9-393c-e053-2995a90ac2df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: ADMA Biologics, Inc
Application: BLA103945
Marketing category: BLA
Marketing start: 2010-03-12
Marketing end: 2022-09-30
Substance: HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active strength: 1560 [iU]/5mL
Pharmacologic classes: Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59730-4203	59730-4203-1	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59730-4203-1	ML - Milliliter	59730-4203	cd2615a0-04f7-425c-8876-35e21e5bf992	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	ACTIVE INGREDIENT	XII270YC6M	NABI-HB (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION [BIOTEST PHARMACEUTICALS CORPORATION]	2
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	ACTIVE MOIETY	XII270YC6M	NABI-HB (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION [BIOTEST PHARMACEUTICALS CORPORATION]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	NABI-HB (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION [BIOTEST PHARMACEUTICALS CORPORATION]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NABI-HB (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION [BIOTEST PHARMACEUTICALS CORPORATION]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NABI-HB (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION [BIOTEST PHARMACEUTICALS CORPORATION]	2

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
Nabi-HB	HEPATITIS B IMMUNE GLOBULIN (HUMAN)	ADMA Biologics, Inc.	47fe1a99-5078-4b89-84fa-9e8387baec5c	2025-04-10	Warnings, Adverse reactions	Exact identifier application number: BLA103945

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103945	Nabi-HB	Hepatitis B Immune Globulin (Human)	351(a)	Disc	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
XII270YC6M	HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59730-4203-1	59730420301	5 mL in 1 VIAL (59730-4203-1)	5 ml	2010-03-12	2022-09-30	No	No	Current