FDA.reportPublic FDA data

Nabi-HB

Product NDC
69800-4202
11-digit product format
698004202
Labeler code
69800
Product ID
69800-4202_ee1560c0-18e1-b617-e053-2a95a90aa1af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hepatitis B Immune Globulin (Human)
Dosage form
LIQUID
Route
INTRAMUSCULAR
Labeler
ADMA Biologics, Inc.
Application
BLA103945
Marketing category
BLA
Marketing start
2001-10-23
Marketing end
0000-00-00
Substance
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active strength
312 [iU]/mL
Pharmacologic classes
Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69800-4202DDiscontinued by firm2026-08-03
excluded packagepackage69800-420269800-4202-1DDiscontinued by firm2026-08-03

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nabi-HBHEPATITIS B IMMUNE GLOBULIN (HUMAN)ADMA Biologics, Inc.47fe1a99-5078-4b89-84fa-9e8387baec5c2025-04-10Warnings, Adverse reactionsExact identifier
application number: BLA103945

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69800-4202-1ML - Milliliter69800-4202d18f3ab9-e899-4f3f-b490-c31373a6d7cc12021-01-08
69800-4202-2ML - Milliliter69800-42024dbda393-4f74-4403-842c-384cd1ead95612021-03-02

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103945Nabi-HBHepatitis B Immune Globulin (Human)351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69800-4202-1698004202011 VIAL, SINGLE-USE in 1 CARTON (69800-4202-1) > 1 mL in 1 VIAL, SINGLE-USE (69800-4202-2) 2001-10-230000-00-00NoNoCurrent