FDA.reportPublic FDA data

TENIVAC

Product NDC
50090-2062
11-digit product format
500902062
Labeler code
50090
Product ID
50090-2062_c4b2e759-0f3e-470e-aae5-048e92315ea2
Type
VACCINE
Nonproprietary name
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
BLA103171
Marketing category
BLA
Marketing start
2010-12-08
Substance
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
5; 2 [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

Additional Listing Data#

Finished product
Yes
Brand name base
TENIVAC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [Lf]/.5mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)2 [Lf]/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2062-0TENIVAC10 in 1 PACKAGEINJECTION, SUSPENSION1014
50090-2062-1TENIVAC.5 mL in 1 SYRINGEINJECTION, SUSPENSION.514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2062-0ML - Milliliter50090-2062fbef2ecb-0093-4a78-97eb-3a8948d38ff912023-07-06
50090-2062-1ML - Milliliter50090-2062991ad29f-bba8-4e02-9903-4c6877c5e5d612024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2062TENIVAC (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]14Current NDC, 2 package rows20230623_db0c7f7c-7624-477d-ab7c-310a903c7025.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103171TenivacTetanus and Diphtheria Toxoids Adsorbed351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190919TENIVAC vaccine 0.5 ML Prefilled SyringePSNdb0c7f7c-7624-477d-ab7c-310a903c702514
807273tetanus and diphtheria toxoids adsorbed (Td) 0.5 ML Prefilled SyringePSNdb0c7f7c-7624-477d-ab7c-310a903c702514
11909190.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Tenivac]SBDdb0c7f7c-7624-477d-ab7c-310a903c702514
8072730.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled SyringeSCDdb0c7f7c-7624-477d-ab7c-310a903c702514
807273diphtheria toxoid vaccine 2 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Prefilled SyringeSYdb0c7f7c-7624-477d-ab7c-310a903c702514
1190919Tenivac (Diphtheria and Tetanus Toxoid Vaccines) 0.5 ML Prefilled SyringeSYdb0c7f7c-7624-477d-ab7c-310a903c702514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-2062-05009020620010 SYRINGE in 1 PACKAGE (50090-2062-0) / .5 mL in 1 SYRINGE (50090-2062-1) 10 syringe2010-12-08NoNoCurrent
50090-2062-150090206201.5 mL in 1 SYRINGEHistorical