TENIVAC
- Product NDC
- 49281-215
- 11-digit product format
- 492810215
- Labeler code
- 49281
- Product ID
- 49281-215_737f89ae-a592-44db-94a4-8a4524ee027f
- Type
- VACCINE
- Nonproprietary name
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Sanofi Vaccines US Inc.
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TENIVAC
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| 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 NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49281-215-10 | TENIVAC | 10 in 1 PACKAGE | INJECTION, SUSPENSION | 10 | | 14 |
| 49281-215-15 | TENIVAC | 10 in 1 PACKAGE | INJECTION, SUSPENSION | 10 | | 14 |
| 49281-215-58 | TENIVAC | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 0.5 | | 14 |
| 49281-215-88 | TENIVAC | 0.5 mL in 1 SYRINGE | INJECTION, SUSPENSION | 0.5 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49281-215 | TENIVAC (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) AND CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) INJECTION, SUSPENSION [SANOFI PASTEUR INC.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240418_1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103171 | Tenivac | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1190916 | TENIVAC vaccine 0.5 ML Injection | PSN | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 1190919 | TENIVAC vaccine 0.5 ML Prefilled Syringe | PSN | db0c7f7c-7624-477d-ab7c-310a903c7025 | 14 |
| 1190919 | TENIVAC vaccine 0.5 ML Prefilled Syringe | PSN | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 807277 | tetanus and diphtheria toxoids adsorbed (Td) 0.5 ML Injection | PSN | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 807273 | tetanus and diphtheria toxoids adsorbed (Td) 0.5 ML Prefilled Syringe | PSN | db0c7f7c-7624-477d-ab7c-310a903c7025 | 14 |
| 807273 | tetanus and diphtheria toxoids adsorbed (Td) 0.5 ML Prefilled Syringe | PSN | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 1190916 | 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Tenivac] | SBD | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 1190919 | 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Tenivac] | SBD | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 1190919 | 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Tenivac] | SBD | db0c7f7c-7624-477d-ab7c-310a903c7025 | 14 |
| 807277 | 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection | SCD | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 807273 | 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe | SCD | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 807273 | 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe | SCD | db0c7f7c-7624-477d-ab7c-310a903c7025 | 14 |
| 807273 | diphtheria toxoid vaccine 2 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Prefilled Syringe | SY | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 807273 | diphtheria toxoid vaccine 2 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Prefilled Syringe | SY | db0c7f7c-7624-477d-ab7c-310a903c7025 | 14 |
| 807277 | diphtheria toxoid vaccine, inactivated 2 UNT / tetanus toxoid vaccine, inactivated 5 UNT per 0.5 ML Injection | SY | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 1190919 | Tenivac (Diphtheria and Tetanus Toxoid Vaccines) 0.5 ML Prefilled Syringe | SY | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
| 1190919 | Tenivac (Diphtheria and Tetanus Toxoid Vaccines) 0.5 ML Prefilled Syringe | SY | db0c7f7c-7624-477d-ab7c-310a903c7025 | 14 |
| 1190916 | Tenivac (Diphtheria Toxoid Vaccine 2 UNT / Tetanus Toxoid Vaccine 5 UNT) per 0.5 ML Injection | SY | 1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c | 14 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49281-215-10 | 49281021510 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58) | | 2010-12-08 | 0000-00-00 | No | No | Current |
| 49281-215-15 | 49281021515 | 10 SYRINGE in 1 PACKAGE (49281-215-15) / .5 mL in 1 SYRINGE (49281-215-88) | 10 syringe | 2010-12-08 | 0000-00-00 | No | No | Current |
| 49281-215-58 | 49281021558 | 0.5 mL in 1 VIAL, SINGLE-DOSE | 0.5 ml | | | | | Historical |
| 49281-215-88 | 49281021588 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | | Historical |