NDC 59730-4203

NABI-HB

Human Hepatitis B Virus Immune Globulin

NABI-HB is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Biotest Pharmaceuticals Corporation. The primary component is Human Hepatitis B Virus Immune Globulin.

• Product ID: 59730-4203_61922151-d9f1-577a-e053-2a91aa0ac777
• NDC: 59730-4203
• Product Type: Human Prescription Drug
• Proprietary Name: NABI-HB
• Generic Name: Human Hepatitis B Virus Immune Globulin
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2010-03-12
• Marketing Category: BLA / BLA
• Application Number: BLA103945
• Labeler Name: Biotest Pharmaceuticals Corporation
• 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: 2019-12-31

Packaging

NDC 59730-4203-1

5 mL in 1 VIAL (59730-4203-1)

• Marketing Start Date: 2010-03-12
• Marketing End Date: 2022-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59730-4203-1 [59730420301]

NABI-HB INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103945
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-03-12
• Marketing End Date: 2022-09-30

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: 8847ff27-8bad-45fd-a9db-594e4f811803
• Manufacturer:
  • Biotest Pharmaceuticals Corporation
• UNII:
  • XII270YC6M
• RxNorm Concept Unique ID - RxCUI:
  • 1658127
  • 1658125

Pharmacological Class

• 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 "Human Hepatitis B Virus Immune Globulin"

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)
70257-053	HepaGam B	human hepatitis B virus immune globulin
70257-054	HepaGam B	human hepatitis B virus immune globulin