NDC 13533-131
TDVAX
Tetanus And Diphtheria Toxoids Adsorbed
TDVAX is a Intramuscular Injection in the Vaccine category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated).
| Product ID | 13533-131_512e4d58-b240-47fe-83c5-f9714682d5fd |
| NDC | 13533-131 |
| Product Type | Vaccine |
| Proprietary Name | TDVAX |
| Generic Name | Tetanus And Diphtheria Toxoids Adsorbed |
| Dosage Form | Injection |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2015-07-01 |
| Marketing Category | BLA / BLA |
| Application Number | BLA101322 |
| Labeler Name | GRIFOLS USA, LLC |
| Substance Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Active Ingredient Strength | 2 [Lf]/.5mL; [Lf]/.5mL |
| Pharm 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 | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 13533-131-01
10 VIAL, SINGLE-DOSE in 1 CARTON (13533-131-01) > .5 mL in 1 VIAL, SINGLE-DOSE (13533-131-00)
| Marketing Start Date | 2015-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 13533-131-00 [13533013100]
TDVAX INJECTION
| Marketing Category | BLA |
| Application Number | BLA101322 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2015-07-01 |
NDC 13533-131-01 [13533013101]
TDVAX INJECTION
| Marketing Category | BLA |
| Application Number | BLA101322 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2015-07-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 2 [Lf]/.5mL |
Pharmacological Class
- 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 Crossover Matching brand name "TDVAX" or generic name "Tetanus And Diphtheria Toxoids Adsorbed"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13533-131 | TDVAX | Tetanus and Diphtheria Toxoids Adsorbed |
| 14362-0111 | TDVAX | Tetanus and Diphtheria Toxoids Adsorbed |
| 21695-413 | Tetanus and Diphtheria Toxoids Adsorbed | Tetanus and Diphtheria Toxoids Adsorbed |
Trademark Results [TDVAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TDVAX 90576269 not registered Live/Pending |
University of Massachusetts 2021-03-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.