NDC 49281-215-10 Tenivac

Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)

NDC Package Code 49281-215-10

The NDC Code 49281-215-10 is assigned to a package of 10 vial, single-dose in 1 package > .5 ml in 1 vial, single-dose (49281-215-58) of Tenivac, a vaccine lable labeled by Sanofi Pasteur Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.This product is billed per "ML" milliliter and contains an estimated amount of 5.0 billable units per package.

Field Name	Field Value
NDC Code	49281-215-10
Package Description	10 VIAL, SINGLE-DOSE in 1 PACKAGE > .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58)
Proprietary Name	Tenivac What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) 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.
Drug Uses	This vaccine is used to help prevent problems that may occur with 2 bacterial infections in children and adults (tetanus and diphtheria). Tetanus (lockjaw) and diphtheria can cause serious, sometimes fatal problems (heart problems, nerve problems, muscle paralysis). Vaccination is the best way to protect (provide immunity) against these life-threatening diseases. Vaccines work by getting the body to make its own protection (antibodies). This vaccine is recommended for all people 7 years and older. Diphtheria and tetanus toxoids combined (adult) injection should not be used in anyone younger than 7 years because they may not be fully protected by this vaccine. A vaccine for children younger than 7 years is available. Consult your child's health care professional for more information.
11-Digit NDC Billing Format	49281021510 NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package	5.0 ML
RxNorm Crosswalk	1190916, 1190919, 807273 and 807277 - RxCUI What is RxNorm? The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type	Vaccine 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.
Labeler Name	Sanofi Pasteur Inc.
Dosage Form	Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s)	Intramuscular - Administration within a muscle.
Active Ingredient(s)	CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2 [Lf]/.5mL
Pharmacological Class(es)	Actively Acquired Immunity - [PE] (Physiologic Effect) Actively Acquired Immunity - [PE] (Physiologic Effect) Diphtheria Toxoid - [CS] Inactivated Clostridium Tetani Vaccine - [EPC] (Established Pharmacologic Class) Inactivated Corynebacterium Diphtheriae Vaccine - [EPC] (Established Pharmacologic Class) Tetanus Toxoid - [CS] Vaccines - Inactivated - [CS] Vaccines - Inactivated - [CS]
Sample Package	No Sample Package? This field Indicates whether this package is a sample packaging or not.
Marketing Category	BLA - A product marketed under an approved Biologic License Application. 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.
FDA Application Number	BLA103171 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.
Start Marketing Date	12-08-2010 What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date	12-31-2022 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.
Exclude Flag	N 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".

NDC Code Structure

49281 - Sanofi Pasteur Inc.
- 49281-215 - Tenivac
  - 49281-215-10 - 10 VIAL, SINGLE-DOSE in 1 PACKAGE

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 49281-215-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
49281021510	90714	Td vacc no presv 7 yrs+ im	0.5 ML	0.5	10	1	10

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Other Product Packages

The following packages are also available for Tenivac with product NDC 49281-215.

NDC Package Code	Package Description
49281-215-15	10 SYRINGE in 1 PACKAGE > .5 mL in 1 SYRINGE (49281-215-88)

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