NDC 13533-131 Tdvax

Tetanus And Diphtheria Toxoids Adsorbed

NDC Product Code 13533-131

NDC CODE: 13533-131

Proprietary Name: Tdvax 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: Tetanus And Diphtheria Toxoids Adsorbed 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 Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • 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.

Product Characteristics


NDC Code Structure

NDC 13533-131-01

Package Description: 10 VIAL, SINGLE-DOSE in 1 CARTON > .5 mL in 1 VIAL, SINGLE-DOSE (13533-131-00)

NDC Product Information

Tdvax with NDC 13533-131 is a a vaccine lable product labeled by Grifols Usa, Llc. The generic name of Tdvax is tetanus and diphtheria toxoids adsorbed. The product's dosage form is injection and is administered via intramuscular form.

Labeler Name: Grifols Usa, Llc

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

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.

Tdvax Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Inactivated Clostridium Tetani Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Vaccines -
  • Inactivated - [CS]
  • Tetanus Toxoid - [CS]
  • Inactivated Corynebacterium Diphtheriae Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Vaccines -
  • Inactivated - [CS]
  • Diphtheria Toxoid - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Grifols Usa, Llc
Labeler Code: 13533
FDA Application Number: BLA101322 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.

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.

Start Marketing Date: 07-01-2015 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 - NO 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".

* Please review the disclaimer below.

Information for Patients

Tetanus, Diphtheria (Td) Vaccine

Tetanus, Diphtheria (Td) Vaccine is

[Read More]

* Please review the disclaimer below.

Tdvax Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Tetanus and Diphtheria Toxoids Adsorbed (Td) manufactured by MassBiologics is a sterile vaccine for intramuscular injection.  After shaking, the vaccine appears as a homogeneous milky white suspension.Each 0.5 ml dose of MassBiologics' Td is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid.  Each 0.5 ml dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (≤ 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process.The Corynebacterium diphtheriae and Clostridium tetani  organisms are grown on modified Mueller's media1,2 which contains bovine extracts.  The bovine material used in these extracts is sourced from countries which the United States Department of Agriculture has determined neither have nor present an undue risk for bovine spongiform encephalopathy.  Tetanus and diphtheria toxins produced during growth of the cultures are detoxified with formaldehyde.  The detoxified materials are then separately purified by ammonium sulfate fractionation.  The diphtheria toxoid is further purified by column chromatography.  The tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.The tetanus and diphtheria toxoids induce at least 2 units and 1 unit of antitoxin per ml of serum, respectively, in the guinea pig potency test.

Clinical Pharmacology

TETANUSTetanus (also known as lockjaw) is a serious, often fatal disease caused by an extremely potent neurotoxin produced by C. tetani.Protection against disease is due to the development of neutralizing antibodies to tetanus toxin.  A serum tetanus antitoxin level of 0.01 IU/ml measured via a neutralization assay is considered the minimum protective level.3,4  The efficacy against tetanus of MassBiologics' Td is supported by the following:1.  Response to primary series.  Of 20 adults with less than 0.0025 units/ml of tetanus antitoxin in pre-immunization serum, 14 (70%) had antitoxin concentrations of 0.01 or greater after 2 doses of Td (2 Lf tetanus toxoid dose).  After 3 doses of Td, 16 of 16 adults achieved 0.01 antitoxin units/ml.2.  Response to booster doses.  Booster doses of Td at doses of 1 Lf and 5 Lf of tetanus toxoid induced tetanus antitoxin levels greater than 0.01 units/ml when administered to all 36 adults who had received prior tetanus immunizations.5DIPHTHERIADiphtheria is an acute toxin-mediated disease caused by toxigenic strains of C. diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin.  A serum diphtheria antitoxin level of 0.01 IU/ml is the lowest level giving some degree of protection.3,6  The efficacy against diphtheria of MassBiologics' Td is supported by the following:1.  Response to primary series.  Of 10 adults with less than 0.001 units/ml of diphtheria antitoxin in pre-immunization serum, 50% had antitoxin concentrations of 0.01 or greater after 2 doses of Td (2 Lf diphtheria toxoid dose).  After 3 doses of Td, 6 of 6 adults achieved 0.01 antitoxin units/ml.2.  Response to booster doses.  In clinical trials, booster doses of Td formulated to contain 1 Lf and 5 Lf of diphtheria toxoid, both induced antitoxin levels greater than 0.01 units/ml when administered to adults with prior diphtheria immunity.5,7,8  In 140 adolescent males given a single booster dose of the 1 Lf formulation, all achieved an antitoxin titer of 0.01 units/ml or higher.8

Indications And Usage

MassBiologics' Td is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria.  This vaccine is approved for use in persons 7 years of age and older.


A severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of MassBiologics’ Td vaccine.  (See DESCRIPTION).  Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out.  Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.


FREQUENCY OF ADMINISTRATIONMore frequent administration of MassBiologics' Td than described in DOSAGE AND ADMINISTRATION may be associated with an increased incidence and severity of adverse reactions.ARTHUS REACTIONSPersons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive MassBiologics' Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management. (See  DOSAGE AND ADMINISTRATION).GUILLAIN-BARRÉ SYNDROMEA review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré Syndrome.9  If Guillain-Barré Syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of MassBiologics' Td or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.10Vaccination with MassBiologics' Td may not protect all individuals.


GENERALEpinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.Prior to the administration of MassBiologics' Td, the vaccine recipient's current health status and health history should be reviewed.  This includes a review of the immunization history of the patient, the presence of any contraindications to immunization, and any adverse events after previous immunizations to allow an assessment of the benefits and risks of vaccination.  (See CONTRAINDICATIONS and WARNINGS).If MassBiologics' Td is administered to immunocompromised persons (whether from disease or treatment) the expected immune response may not be obtained.INFORMATION FOR PATIENTSPrior to administration of MassBiologics' Td, patients, parents or guardians should be informed by the health care provider of the benefits and risks of immunization with Td and of the importance of completing the primary immunization series or receiving recommended booster doses.The health care provider should inform the patient, parent, or guardian of the potential for adverse reactions that have been temporally associated with MassBiologics' Td or other vaccines containing similar ingredients.  Patients, parents or guardians should be instructed to report any suspected adverse reactions to their health care provider.According to the National Childhood Vaccine Injury Act of 1986, Vaccine Information Statements must be provided by the health care provider with each vaccine dose administered.10DRUG INTERACTIONSPatients who are on immunosuppressive therapy, including alkylating agents, antimetabolites, cytotoxic drugs, irradiation, or corticosteroids (used in greater than physiologic doses), may have a reduced immune response to vaccines.No safety and immunogenicity data are available on the concomitant administration of MassBiologics' Td vaccine with other U.S. licensed vaccines.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITYNo studies have been performed with MassBiologics' Td to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.PREGNANCY CATEGORY CAnimal reproduction studies have not been conducted with MassBiologics' Td.  It is also not known whether MassBiologics' Td can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  MassBiologics' Td should be given to a pregnant woman only if clearly needed.NURSING MOTHERSIt is not known whether MassBiologics' Td is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when MassBiologics' Td is administered to a nursing woman.PEDIATRIC USEMassBiologics' Td is not approved for use in infants and children younger than 7 years of age.  The safety and effectiveness of MassBiologics' Td in this age group have not been established.GERIATRIC USENo studies have been performed with MassBiologics' Td in adults aged 65 years and older in order to determine whether they respond differently than younger subjects.

Adverse Reactions

DATA FROM CLINICAL TRIALSBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. However, the adverse reaction information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating rates. Data on adverse reactions following fluid and adsorbed preparations of MassBiologics' Td with various doses of the diphtheria and tetanus components have been reported in a series of studies.5,7,8,11,12POSTMARKETING REPORTSThe following adverse events have been identified during post-approval use of MassBiologics' Td. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to vaccination. The following adverse events were included because of seriousness or frequency of reporting:General Disorders and Administration Site Conditions: Injection site reactions, including pain, tenderness, erythema, induration, pruritis, swelling and warmth; peripheral oedema, pyrexia, malaiseNervous System Disorders: Dizziness, headache, convulsionsMusculoskeletal and Connective Tissue Disorders: Myalgia, musculoskeletal stiffness or pain, arthralgiaSkin and Subcutaneous Tissue Disorders: RashGastrointestinal Disorders: NauseaInfections and Infestations: CellulitisREPORTING OF SUSPECTED ADVERSE REACTIONSTo report SUSPECTED ADVERSE REACTIONS, contact MassBiologics at 1-800-457-4626 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Dosage And Administration

PRIMARY IMMUNIZATIONMassBiologics' Td may be used in persons 7 years of age and older who have not been previously immunized against tetanus and diphtheria, as a primary immunization series consisting of three 0.5 ml doses.  The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose.MassBiologics'  Td may be used to complete the primary immunization series for tetanus and diphtheria, following one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT) vaccine.  However, the safety and efficacy of MassBiologics' Td in such regimens have not been evaluated.ROUTINE BOOSTER IMMUNIZATIONMassBiologics' Td may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria.  Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.10The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.10,13,14TETANUS PROPHYLAXIS IN WOUND MANAGEMENT For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.15 MassBiologics' Td is approved for wound management of patients 7 years of age and older.    The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert.  If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.15TABLE 1  GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT IN PERSONS AGED 7 YEARS AND OLDER 13,14,15History of Adsorbed Tetanus Toxoid (Doses)Clean, Minor WoundsAll Other Wounds*Td†TIGTd†TIGUnknown or < 3YesNoYesYes≥ 3 ‡No§NoNo¶No* Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.† The ACIP has specific recommendations on use of Td or Tetanus Toxoid, Reduced Diphtheria Toxoids and Acellular Pertussis Vaccine Adsorbed (Tdap) in adolescents and adults.13,14‡ If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.§ Yes, if ≥ 10 years since the last tetanus toxoid-containing vaccine dose.¶ Yes, if ≥ 5 years since the last tetanus toxoid-containing vaccine dose.  (More frequent boosters are not needed and can accentuate side effects.)DIPHTHERIA PROPHYLAXIS FOR CASE CONTACTSMassBiologics' Td may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years.  Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis.15ADMINISTRATIONShake the vial well to resuspend the vaccine before withdrawing the dose.  After shaking, MassBiologics' Td is a homogenous milky white suspension.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  If these conditions exist, MassBiologics' Td should not be administered.Inject 0.5 ml of MassBiologics' Td intramuscularly.  The preferred site is the deltoid muscle.  The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.Do not administer this vaccine intravenously, subcutaneously, or intradermally.MassBiologics' Td should not be combined through reconstitution or mixed with any other vaccine.

How Supplied

The stopper of the vial is latex free.MassBiologics’ Td is supplied in a package of 10 single dose vials.NDC No. 13533-131-00 is the code for individual single dose (0.5ml) vials.NDC No. 13533-131-01 is the code for the package containing ten vials.


Store at 2°C - 8°C (36°F - 46°F).  DO NOT FREEZE.  Discard product if exposed to freezing.Do not use vaccine after expiration date.


1. Latham WC, Bent DF, and Levine L. Tetanus toxin production in the absence of protein. Appl. Microbiol. 10(2): March 1962;146-152.2. Mueller JH and Miller PA. Production of diphtheric toxin of high potency (100 Lf) on a reproducible medium. J. Immunol. 40: 1941;21-32.3. Food and Drug Administration. Department of Health and Human Services (DHHS). Biological Products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Fed Reg 1985;50(240): 51002-117.4. Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 805-839.5. Ipsen J. Jr. Immunization of adults against diphtheria and tetanus. NEJM. 1954; 251:459-4666. Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 139-156.7. Edsall G, Altman JS, and Gaspar AJ. Combined tetanus-diphtheria immunization of adults: Use of small doses of diphtheria toxoid. Am J Public Health Nations Health. 1954 Dec;44(12):1537-1545.8. Levine L, Ipsen J, and McComb JA. Adult immunization: preparation and evaluation of combined fluid tetanus and diphtheria toxoids for adult use. Am. J. Hyg. 1961;73:20-35.9. Institute of Medicine. Stratton KR, et al, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Casuality. Washington D.C.: National Academy Press. 1994:67-117.10. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-15):1-48.11. McComb JA and Levine L. Adult immunization II. Dosage reduction as a solution to increasing reactions to tetanus toxoid. NEJM. 1961;256:1152-1158.12. Levine L and Edsall G. Tetanus toxoid: What determines reaction proneness? J. Infect. Dis. 1981;144:376.13. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-3):1-43.14. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR 2006;55(No. RR-17):1-37.15. Centers for Disease Control and Prevention. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures. MMWR 1991;40(No. RR-10):1-35.Manufactured by:MassBiologicsUniversity of Massachusetts Medical SchoolBoston, MA 02126US Government License No. 1779Distributed by:Grifols USA, LLCLos Angeles, CA 90032Product information as of February 2015

* Please review the disclaimer below.