NDC 71665-330 Acam2000

Smallpox (vaccinia) Vaccine,Live Injection, Powder, Lyophilized, For Solution Percutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
71665-330
Proprietary Name:
Acam2000
Non-Proprietary Name: [1]
Smallpox (vaccinia) Vaccine, Live
Substance Name: [2]
Vaccinia Virus Strain New York City Board Of Health Live Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Percutaneous - Administration through the skin.
  • Labeler Name: [5]
    Emergent Product Development Gaithersburg Inc.
    Labeler Code:
    71665
    FDA Application Number: [6]
    BLA125158
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    08-31-2007
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 71665-330-02

    Package Description: 50 VIAL, MULTI-DOSE in 1 CARTON / .3 mL in 1 VIAL, MULTI-DOSE (71665-330-01)

    Product Details

    What is NDC 71665-330?

    The NDC code 71665-330 is assigned by the FDA to the product Acam2000 which is a vaccine label product labeled by Emergent Product Development Gaithersburg Inc.. The generic name of Acam2000 is smallpox (vaccinia) vaccine, live. The product's dosage form is injection, powder, lyophilized, for solution and is administered via percutaneous form. The product is distributed in a single package with assigned NDC code 71665-330-02 50 vial, multi-dose in 1 carton / .3 ml in 1 vial, multi-dose (71665-330-01). 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 Acam2000?

    ACAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

    What are Acam2000 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 Acam2000 UNII Codes?

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

    • VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK)
    • VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK) (Active Moiety)

    Which are Acam2000 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 Acam2000?

    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: 833082 - smallpox (vaccinia) vaccine, live Injectable Solution
    • RxCUI: 833082 - smallpox vaccine live, New York City Board of Health vaccinia strain 500000000 UNT/ML Injectable Solution
    • RxCUI: 833086 - ACAM2000 smallpox (vaccinia) vaccine, live Injectable Solution
    • RxCUI: 833086 - smallpox vaccine live, New York City Board of Health vaccinia strain 500000000 UNT/ML Injectable Solution [ACAM2000]
    • RxCUI: 833086 - ACAM2000 500000000 UNT/ML Injectable Solution

    Which are the Pharmacologic Classes for Acam2000?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Smallpox/Monkeypox Vaccine


    Why get vaccinated? Smallpox/Monkeypox vaccine can prevent infection with some types of orthopoxviruses including Smallpox, Monkeypox, and Vaccinia viruses. Smallpox infection can cause a serious illness characterized by rash and fever that may result in death, for some. Monkeypox infection can cause an illness similar to Smallpox. Although generally milder, it can still cause death. Vaccinia virus infection can occur after someone is exposed to a person or an animal who has been exposed to the virus. It generally causes a self-limiting illness.
    [Learn More]


    * 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".