NDC 13533-318

HyperRAB

Rabies Immune Globulin (human)

HyperRAB is a Infiltration; Intramuscular Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Rabies Virus Immune Globulin.

Product ID13533-318_0773312c-a8b5-4092-a770-ac6798abc153
NDC13533-318
Product TypePlasma Derivative
Proprietary NameHyperRAB
Generic NameRabies Immune Globulin (human)
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION; INTRAMUSCULAR
Marketing Start Date1974-06-12
Marketing CategoryBLA / BLA
Application NumberBLA101144
Labeler NameGRIFOLS USA, LLC
Substance NameHUMAN RABIES VIRUS IMMUNE GLOBULIN
Active Ingredient Strength300 [iU]/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13533-318-01

1 VIAL in 1 CARTON (13533-318-01) > 1 mL in 1 VIAL (13533-318-10)
Marketing Start Date1974-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13533-318-05 [13533031805]

HyperRAB INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101144
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1974-06-12

NDC 13533-318-30 [13533031830]

HyperRAB INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101144
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2019-12-20

NDC 13533-318-01 [13533031801]

HyperRAB INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101144
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1974-06-12

NDC 13533-318-10 [13533031810]

HyperRAB INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101144
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1974-06-12

NDC 13533-318-03 [13533031803]

HyperRAB INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101144
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2019-12-20

NDC 13533-318-50 [13533031850]

HyperRAB INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101144
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date1974-06-12

Drug Details

Active Ingredients

IngredientStrength
HUMAN RABIES VIRUS IMMUNE GLOBULIN300 [iU]/mL

NDC Crossover Matching brand name "HyperRAB" or generic name "Rabies Immune Globulin (human)"

NDCBrand NameGeneric Name
13533-318HyperRABRabies Immune Globulin (Human)
13533-618HYPERRABRABIES IMMUNE GLOBULIN (HUMAN)

Trademark Results [HyperRAB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYPERRAB
HYPERRAB
78622898 3206857 Live/Registered
GRIFOLS THERAPEUTICS LLC
2005-05-04

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