NDC 49281-286 Daptacel
Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated),Clostridium Tetani - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 49281 - Sanofi Pasteur Inc.
- 49281-286 - Daptacel
Product Characteristics
Product Packages
NDC Code 49281-286-01
Package Description: 1 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-286-58)
NDC Code 49281-286-05
Package Description: 5 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-286-58)
NDC Code 49281-286-10
Package Description: 10 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-286-58)
Product Details
What is NDC 49281-286?
What are the uses for Daptacel?
What are Daptacel Active Ingredients?
- BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 5 ug/.5mL
- BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug/.5mL
- BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug/.5mL
- BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 10 ug/.5mL
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL
- CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf]/.5mL
Which are Daptacel UNII Codes?
The UNII codes for the active ingredients in this product are:
- CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H)
- CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (Active Moiety)
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13)
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (Active Moiety)
- BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37)
- BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37) (Active Moiety)
- BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY)
- BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (Active Moiety)
- BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X)
- BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X) (Active Moiety)
- BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A)
- BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A) (Active Moiety)
Which are Daptacel 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:
- ALUMINUM PHOSPHATE (UNII: F92V3S521O)
- FORMALDEHYDE (UNII: 1HG84L3525)
- GLUTARAL (UNII: T3C89M417N)
- PHENOXYETHANOL (UNII: HIE492ZZ3T)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for Daptacel?
- RxCUI: 1300308 - diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP generic for Daptacel) 0.5 ML Injection
- RxCUI: 1300308 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.02 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection
- RxCUI: 1300308 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 5 MCG / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 5 MCG / Bordetella pertussis pertactin vaccine, inactivated 3 MCG / Bordetella pertussis toxoid vaccine, inactivated 10 MCG / diphtheria toxoid vaccine 15 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection
- RxCUI: 1300308 - DTaP (diphtheria toxoid vaccine, inactivated 15 UNT / tetanus toxoid vaccine, inactivated 5 UNT / acellular pertussis vaccine, inactivated 23 MCG) per 0.5 ML Injection
- RxCUI: 1300310 - DAPTACEL vaccine 0.5 ML Injection
Which are the Pharmacologic Classes for Daptacel?
- Actively Acquired Immunity - [PE] (Physiologic Effect)
- Actively Acquired Immunity - [PE] (Physiologic Effect)
- Diphtheria Toxoid - [CS]
- Inactivated Bordetella Pertussis Vaccine - [EPC] (Established Pharmacologic Class)
- Inactivated Clostridium Tetani Vaccine - [EPC] (Established Pharmacologic Class)
- Inactivated Corynebacterium Diphtheriae Vaccine - [EPC] (Established Pharmacologic Class)
- Pertussis Vaccine - [CS]
- Tetanus Toxoid - [CS]
- Vaccines, Inactivated - [CS]
* 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".