Home NDC 69800-4203 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# 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 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 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 Ingredient Strength HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 1560 [iU]/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XII270YC6M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658125 Internal RxNorm lookup 1658127 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69800-4203-1 Nabi-HB 1 in 1 CARTON LIQUID 1 8 69800-4203-2 Nabi-HB 5 mL in 1 VIAL, SINGLE-USE LIQUID 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69800-4203 NABI-HB (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) LIQUID [ADMA BIOLOGICS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250416_47fe1a99-5078-4b89-84fa-9e8387baec5c.zip
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69800-4203-1 69800420301 1 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) / 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2) 2001-10-23 0000-00-00 No No Current 69800-4203-2 69800420302 5 mL in 1 VIAL, SINGLE-USE 5 ml Historical