NDC 0008-0423

North American Coral Snake Antivenin (Equine)

Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)

North American Coral Snake Antivenin (Equine) is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine).

Product ID0008-0423_52d0cf5a-e3d9-4705-8b50-9ca7c8c78578
NDC0008-0423
Product TypeHuman Prescription Drug
Proprietary NameNorth American Coral Snake Antivenin (Equine)
Generic NameCoral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-10-12
Marketing CategoryBLA / BLA
Application NumberBLA101099
Labeler NameWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Substance NameCORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)
Active Ingredient Strength250 [arb'U]/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0008-0423-03

1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01)
Marketing Start Date2016-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0008-0423-01 [00008042301]

North American Coral Snake Antivenin (Equine) INJECTION, POWDER, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA101099
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-12

NDC 0008-0423-03 [00008042303]

North American Coral Snake Antivenin (Equine) INJECTION, POWDER, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA101099
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-12

Drug Details

Active Ingredients

IngredientStrength
CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)250 [arb'U]/10mL

OpenFDA Data

SPL SET ID:6d0f94b4-82ca-37c7-edb0-4f0702cf6c8d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1858981
  • UPC Code
  • 0300080423035

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