NDC 13533-636

HYPERHEP B

Hepatitis B Immune Globulin (human)

HYPERHEP B is a Intramuscular Injection in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Hepatitis B Virus Immune Globulin.

Product ID13533-636_391b2218-8a15-4e5e-8717-aa49efcc2210
NDC13533-636
Product TypePlasma Derivative
Proprietary NameHYPERHEP B
Generic NameHepatitis B Immune Globulin (human)
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1996-10-09
Marketing CategoryBLA / BLA
Application NumberBLA101146
Labeler NameGRIFOLS USA, LLC
Substance NameHUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active Ingredient Strength220 [iU]/mL
Pharm ClassesHuman Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 13533-636-01

1 VIAL, GLASS in 1 CARTON (13533-636-01) > 1 mL in 1 VIAL, GLASS (13533-636-10)
Marketing Start Date1996-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13533-636-05 [13533063605]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1996-10-09

NDC 13533-636-50 [13533063650]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-11-29

NDC 13533-636-20 [13533063620]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-11-29

NDC 13533-636-03 [13533063603]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1996-10-09

NDC 13533-636-30 [13533063630]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-11-29

NDC 13533-636-02 [13533063602]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1996-10-09

NDC 13533-636-01 [13533063601]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1996-10-09

NDC 13533-636-10 [13533063610]

HYPERHEP B S/D INJECTION
Marketing CategoryBLA
Application NumberBLA101146
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-11-29

Drug Details

Active Ingredients

IngredientStrength
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN220 [iU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "HYPERHEP B" or generic name "Hepatitis B Immune Globulin (human)"

NDCBrand NameGeneric Name
13533-636HYPERHEP BHEPATITIS B IMMUNE GLOBULIN (HUMAN)
53270-0051HepaGam BHepatitis B Immune Globulin (Human)
53270-0052HepaGam BHepatitis B Immune Globulin (Human)
70504-0051HepaGam BHepatitis B Immune Globulin (Human)
70504-0052HepaGam BHepatitis B Immune Globulin (Human)
70504-0053HepaGam BHepatitis B Immune Globulin (Human)
70504-0054HepaGam BHepatitis B Immune Globulin (Human)
69800-4202Nabi-HBHepatitis B Immune Globulin (Human)
69800-4203Nabi-HBHepatitis B Immune Globulin (Human)

Trademark Results [HYPERHEP B]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYPERHEP B
HYPERHEP B
78622916 3197566 Live/Registered
GRIFOLS THERAPEUTICS LLC
2005-05-04

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