FDA.reportPublic FDA data

Nabi-HB

Product NDC
69800-4203
11-digit product format
698004203
Labeler code
69800
Product ID
69800-4203_3271ce4f-1742-b3b7-e063-6294a90a541d
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
Substance
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active strength
1560 [iU]/5mL
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
2026-12-31
Current FDA listing
Yes

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
ndc (product): 69800-4203

Additional Listing Data#

Finished product
Yes
Brand name base
Nabi-HB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN1560 [iU]/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XII270YC6MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1658125Internal RxNorm lookup
1658127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47fe1a99-5078-4b89-84fa-9e8387baec5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69800-4203-1Nabi-HB1 in 1 CARTONLIQUID18
69800-4203-2Nabi-HB5 mL in 1 VIAL, SINGLE-USELIQUID58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69800-4203-1ML - Milliliter69800-4203be101627-e458-4828-8b33-eaff2cf7c73e12021-01-08
69800-4203-2ML - Milliliter69800-4203c4b8a4fe-1ffa-4007-8d04-aff9e3b814c712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69800-4203NABI-HB (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) LIQUID [ADMA BIOLOGICS, INC.]8Current NDC, Legacy NDC, 2 package rows20250416_47fe1a99-5078-4b89-84fa-9e8387baec5c.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658125hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML InjectionPSN47fe1a99-5078-4b89-84fa-9e8387baec5c8
1658127Nabi-HB > 1560 UNT in 5 ML InjectionPSN47fe1a99-5078-4b89-84fa-9e8387baec5c8
16581275 ML hepatitis B immune globulin 312 UNT/ML Injection [Nabi-HB]SBD47fe1a99-5078-4b89-84fa-9e8387baec5c8
16581255 ML hepatitis B immune globulin 312 UNT/ML InjectionSCD47fe1a99-5078-4b89-84fa-9e8387baec5c8
16581275 ML Nabi-HB 312 UNT/ML InjectionSY47fe1a99-5078-4b89-84fa-9e8387baec5c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69800-4203-1698004203011 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) / 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2) 2001-10-230000-00-00NoNoCurrent
69800-4203-2698004203025 mL in 1 VIAL, SINGLE-USE5 mlHistorical