NDC 71665-330 Acam2000
Smallpox (vaccinia) Vaccine,Live Injection, Powder, Lyophilized, For Solution Percutaneous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 71665 - Emergent Product Development Gaithersburg Inc.
- 71665-330 - Acam2000
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?
What are the uses for Acam2000?
What are Acam2000 Active Ingredients?
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:
- ALBUMIN HUMAN (UNII: ZIF514RVZR)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- MANNITOL (UNII: 3OWL53L36A)
What is the NDC to RxNorm Crosswalk for Acam2000?
- 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?
* 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.
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* Please review the disclaimer below.
[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".