Yf-vax Injection, Powder, Lyophilized, For Suspension
NDC 49281-915
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Yf-vax (yellow fever virus strain 17d-204 live antigen) is a BLA-approved product labeled by Sanofi Vaccines Us Inc.. This medication is typically used as a actively acquired immunity [pe]. It is supplied as a injection, powder, lyophilized, for suspension for subcutaneous administration. This product entry covers the primary NDC 49281-915 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
49281-915
Proprietary Name:
Yf-vax
Non-Proprietary Name: [1]
Yellow Fever Virus Strain 17d-204 Live Antigen
Substance Name: [2]
Yellow Fever Virus Strain 17d-204 Live Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Powder, Lyophilized, For Suspension
- A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
49281
Product Label ID:
FDA Application Number: [6]
BLA103915
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
05-22-1953
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 49281-915?
The NDC code 49281-915 is assigned by the FDA to the product Yf-vax. It is commonly known by its generic name, yellow fever virus strain 17d-204 live antigen. This pharmaceutical product is labeled by Sanofi Vaccines Us Inc. and is currently categorized as listed product. The medication is a injection, powder, lyophilized, for suspension administered via subcutaneous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 49281-915-01, 49281-915-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories:
What are Active Ingredients of this product?
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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN (UNII: PY4EET359T)
- YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN (UNII: PY4EET359T) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- SORBITOL (UNII: 506T60A25R)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
What is the NDC to RxNorm Crosswalk for this product?
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: 1292826 - yellow fever vaccine (generic for YF-Vax) Injectable Suspension
- RxCUI: 1292826 - yellow fever virus strain 17D-204 live antigen 4000 UNT/ML Injectable Suspension
- RxCUI: 1292828 - YF-VAX Injectable Suspension
- RxCUI: 1292828 - yellow fever virus strain 17D-204 live antigen 4000 UNT/ML Injectable Suspension [YF-Vax]
- RxCUI: 1292828 - YF-Vax 4000 UNT/ML Injectable Suspension
Which are the Pharmacologic Classes of this product?
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.
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Patient Education
Yellow Fever Vaccine
What is yellow fever? Yellow fever is a serious disease caused by the yellow fever virus. It is found in certain parts of Africa and South America. Yellow fever is spread through the bite of an infected mosquito. It cannot be spread person to person by direct contact. People with yellow fever disease usually have to be hospitalized. Yellow fever can cause: fever and flu-like symptoms jaundice (yellow skin or eyes) bleeding from multiple body sites liver, kidney, respiratory and other organ failure death (20 to 50% of serious cases) Yellow fever vaccine is a live, weakened virus. It is given as a single shot. For people who remain at risk, a booster dose is recommended every 10 years. Yellow fever vaccine may be given at the same time as most other vaccines.
[Learn More]
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
