FDA.reportPublic FDA data

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED

Product NDC
49281-225
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
Substance
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
5; 25 [Lf]/.5mL; [Lf]/.5mL
Pharmacologic classes
Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49281-225DDiscontinued by firm2026-07-31
excluded packagepackage49281-22549281-225-10DDiscontinued by firm2026-07-31

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.]8Current NDC, Legacy 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)Disc2026-06-01

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
49281-225-58492810225580.5 mL in 1 VIAL0.5 mlHistorical