FDA.reportPublic FDA data

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED

Product NDC
49281-225
Requested package NDC
49281-225-10
11-digit product format
492810225
Labeler code
49281
Product ID
49281-225_c05b35c2-928a-4388-84ed-051ea390f18e
Type
VACCINE
Nonproprietary name
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA103944
Marketing category
BLA
Marketing start
2010-03-29
Marketing end
0000-00-00
Substance
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
25 [Lf]/.5mL; [Lf]/.5mL
Pharmacologic classes
Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49281-22549281-225-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-225-10DIPHTHERIA AND TETANUS TOXOIDS ADSORBED10 in 1 PACKAGEINJECTION, SUSPENSION108
49281-225-58DIPHTHERIA AND TETANUS TOXOIDS ADSORBED0.5 mL in 1 VIALINJECTION, SUSPENSION0.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-225-10ML - Milliliter49281-225c59c4be1-99aa-4670-b86b-a3913924a85112013-02-19
49281-225-58ML - Milliliter49281-2257d552300-1f37-47a1-82af-7c3760dd201e12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTK3W1N8YP13DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]5
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTIRH51QN26HDIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]5
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYK3W1N8YP13DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]5
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYIRH51QN26HDIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]5
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521ODIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]5
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-225DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.]8Legacy NDC, 2 package rows20190502_ce88effe-7ff2-418f-acb3-3cb5d5d2bf95.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103944Diphtheria & Tetanus Toxoids Adsorbed351(a)Disc2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244205diphtheria toxoid vaccine 25 UNT/ML / tetanus toxoid vaccine (DT) 5 UNT in 0.5 ML InjectionPSNce88effe-7ff2-418f-acb3-3cb5d5d2bf958
12442050.5 ML diphtheria toxoid vaccine, inactivated 50 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML InjectionSCDce88effe-7ff2-418f-acb3-3cb5d5d2bf958
1244205diphtheria toxoid vaccine 25 UNT/ML / tetanus toxoid vaccine 5 UNT per 0.5 ML InjectionSYce88effe-7ff2-418f-acb3-3cb5d5d2bf958

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-225-104928102251010 VIAL in 1 PACKAGE (49281-225-10) > .5 mL in 1 VIAL (49281-225-58) 10 vial2010-03-290000-00-00NoNoCurrent