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  4. NDC Product Code: 0008-0423 North American Coral Snake Antivenin (equine)

NDC 0008-0423 North American Coral Snake Antivenin (equine)

Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine) Injection, Powder, For - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0008-0423?
  4. North American Coral Snake Antivenin (equine) Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0008-0423
Proprietary Name:
North American Coral Snake Antivenin (equine)
Non-Proprietary Name: [1]
Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)
Substance Name: [2]
Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
    Labeler Code:
    0008
    Product Label ID:
    6d0f94b4-82ca-37c7-edb0-4f0702cf6c8d
    FDA Application Number: [6]
    BLA101099
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-12-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0008-0423-03

    Package Description: 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (0008-0423-01)

    Product Details

    What is NDC 0008-0423?

    The NDC code 0008-0423 is assigned by the FDA to the product North American Coral Snake Antivenin (equine) which is a human prescription drug product labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The generic name of North American Coral Snake Antivenin (equine) is coral snake (micrurus fulvius) immune globulin antivenin (equine). The product's dosage form is injection, powder, for solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0008-0423-03 1 vial in 1 carton / 10 ml in 1 vial (0008-0423-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for North American Coral Snake Antivenin (equine)?

    North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).

    What are North American Coral Snake Antivenin (equine) Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are North American Coral Snake Antivenin (equine) UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (UNII: Y605XBM2GL)
    • CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (UNII: Y605XBM2GL) (Active Moiety)

    Which are North American Coral Snake Antivenin (equine) Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for North American Coral Snake Antivenin (equine)?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1858981 - North American coral snake antivenin in 10 ML Injection
    • RxCUI: 1858981 - North American coral snake antivenin 250 UNT Injection
    • RxCUI: 1858981 - North American coral snake antivenin 250 [arb'U] per 10 ML Injection

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".