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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69800-4202DDiscontinued by firm2026-08-17
excluded packagepackage69800-420269800-4202-1DDiscontinued by firm2026-08-17

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69800-4202-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69800-4202-1f5e01cc5f278…a2eaf40c39c3…

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

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
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103945Nabi-HBHepatitis B Immune Globulin (Human)351(a)Disc2026-07-01

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