NDC 69800-4203

Nabi-HB

Hepatitis B Immune Globulin (human)

Nabi-HB is a Intramuscular Liquid in the Human Prescription Drug category. It is labeled and distributed by Adma Biologics, Inc.. The primary component is Human Hepatitis B Virus Immune Globulin.

• Product ID: 69800-4203_739a1a44-e3bc-4ef7-a928-cfa9d8c80c5f
• NDC: 69800-4203
• Product Type: Human Prescription Drug
• Proprietary Name: Nabi-HB
• Generic Name: Hepatitis B Immune Globulin (human)
• Dosage Form: Liquid
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2001-10-23
• Marketing Category: BLA / BLA
• Application Number: BLA103945
• Labeler Name: ADMA Biologics, Inc.
• Substance Name: HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
• Active Ingredient Strength: 1560 [iU]/5mL
• Pharm Classes: Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69800-4203-1

1 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) > 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2)

• Marketing Start Date: 2001-10-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69800-4203-1 [69800420301]

Nabi-HB LIQUID

• Marketing Category: BLA
• Application Number: BLA103945
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-10-23

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	1560 [iU]/5mL

OpenFDA Data

• SPL SET ID: 47fe1a99-5078-4b89-84fa-9e8387baec5c
• Manufacturer:
  • ADMA Biologics, Inc.
• UNII:
  • XII270YC6M
• RxNorm Concept Unique ID - RxCUI:
  • 1658148
  • 1658127
  • 1658125
  • 1658147
• UPC Code:
  • 0369800420310
  • 0369800420211

Pharmacological Class

• Human Immunoglobulin [EPC]
• Passively Acquired Immunity [PE]
• Virus Neutralization [MoA]
• Virus-specific Hyperimmune Globulins [EXT]
• Immunoglobulins [CS]
• Human Immunoglobulin [EPC]
• Passively Acquired Immunity [PE]
• Virus Neutralization [MoA]
• Virus-specific Hyperimmune Globulins [EXT]
• Immunoglobulins [CS]

NDC Crossover Matching brand name "Nabi-HB" or generic name "Hepatitis B Immune Globulin (human)"

NDC	Brand Name	Generic Name
59730-4202	NABI-HB	HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
59730-4203	NABI-HB	HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
69800-4202	Nabi-HB	Hepatitis B Immune Globulin (Human)
69800-4203	Nabi-HB	Hepatitis B Immune Globulin (Human)
53270-0051	HepaGam B	Hepatitis B Immune Globulin (Human)
53270-0052	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0051	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0052	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0053	HepaGam B	Hepatitis B Immune Globulin (Human)
70504-0054	HepaGam B	Hepatitis B Immune Globulin (Human)
13533-636	HYPERHEP B	HEPATITIS B IMMUNE GLOBULIN (HUMAN)