FDA.reportPublic FDA data

TDVAX

Product NDC
14362-0111
11-digit product format
143620111
Labeler code
14362
Product ID
14362-0111_06873f1f-4203-4697-a0ae-c2eaa8f6c668
Type
VACCINE
Nonproprietary name
Tetanus and Diphtheria Toxoids Adsorbed
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
MassBiologics
Application
BLA101322
Marketing category
BLA
Marketing start
1970-07-27
Marketing end
0000-00-00
Substance
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
2 [Lf]/.5mL; [Lf]/.5mL
Pharmacologic classes
Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14362-0111DDiscontinued by firm2026-10-05
excluded packagepackage14362-011114362-0111-4DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14362-0111-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14362-0111-4f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14362-0111-3ML - Milliliter14362-011111573231-33b9-4973-acb0-bfcd45927a7412013-02-13
14362-0111-4ML - Milliliter14362-01117eb88679-482e-4ac1-b4b4-bb6228e2281d12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTK3W1N8YP13TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTIRH51QN26HTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYK3W1N8YP13TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYIRH51QN26HTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521OTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
THIMEROSALINACTIVE INGREDIENT2225PI3MOVTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [MASSBIOLOGICS]5
CLOSTRIDIUM TETANIACTIVE INGREDIENT751E8J54VMTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [REBEL DISTRIBUTORS]1
CORYNEBACTERIUM DIPHTHERIAEACTIVE INGREDIENT3U7E3O07S8TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [REBEL DISTRIBUTORS]1
CLOSTRIDIUM TETANIACTIVE MOIETY751E8J54VMTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [REBEL DISTRIBUTORS]1
CORYNEBACTERIUM DIPHTHERIAEACTIVE MOIETY3U7E3O07S8TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [REBEL DISTRIBUTORS]1
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521OTETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [REBEL DISTRIBUTORS]1
FormaldehydeINACTIVE INGREDIENT1HG84L3525TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [REBEL DISTRIBUTORS]1

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101322TdvaxTetanus and Diphtheria Toxoids Adsorbed351(a)Disc2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205259tetanus toxoid vaccine, inactivated 2 UNT / diphtheria toxoid vaccine, inactivated (Td) 2 UNT in 0.5 ML InjectionPSN70bfb8c1-6d1a-4b0a-8a21-7a7ed8e748c91
2052590.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 4 UNT/ML InjectionSCD70bfb8c1-6d1a-4b0a-8a21-7a7ed8e748c91
205259tetanus toxoid vaccine, inactivated 2 UNT / diphtheria toxoid vaccine, inactivated 2 UNT per 0.5 ML InjectionSY70bfb8c1-6d1a-4b0a-8a21-7a7ed8e748c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14362-0111-41436201110410 VIAL, SINGLE-DOSE in 1 CARTON (14362-0111-4) > .5 mL in 1 VIAL, SINGLE-DOSE (14362-0111-3) 1970-07-270000-00-00NoNoCurrent