TDVAX
- Product NDC
- 13533-131
- 11-digit product format
- 135330131
- Labeler code
- 13533
- Product ID
- 13533-131_5865c299-a006-446f-b9ce-7361b679ad6a
- Type
- VACCINE
- Nonproprietary name
- Tetanus and Diphtheria Toxoids Adsorbed
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA101322
- Marketing category
- BLA
- Marketing start
- 2015-07-01
- 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#
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 13533-131 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 13533-131 | 13533-131-01 | D | Discontinued by firm | 2026-07-31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13533-131-00 | ML - Milliliter | 13533-131 | 080b2054-155e-4308-863e-d0807f451225 | 1 | 2015-07-20 |
| 13533-131-01 | ML - Milliliter | 13533-131 | 8a0cfb58-6986-4a08-855c-b5914904427f | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE INGREDIENT | K3W1N8YP13 | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 | |
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE INGREDIENT | IRH51QN26H | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 | |
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE MOIETY | K3W1N8YP13 | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 | |
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | ACTIVE MOIETY | IRH51QN26H | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 | |
| ALUMINUM PHOSPHATE | INACTIVE INGREDIENT | F92V3S521O | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 | |
| FORMALDEHYDE | INACTIVE INGREDIENT | 1HG84L3525 | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 | |
| THIMEROSAL | INACTIVE INGREDIENT | 2225PI3MOV | TETANUS AND DIPHTHERIA TOXOIDS ADSORBED INJECTION [GRIFOLS] | 1 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 101322 | Tdvax | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | Disc | 2026-06-01 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13533-131-01 | 13533013101 | 10 VIAL, SINGLE-DOSE in 1 CARTON (13533-131-01) > .5 mL in 1 VIAL, SINGLE-DOSE (13533-131-00) | 2015-07-01 | 0000-00-00 | No | No | Current |