CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN
- Product NDC
- 50090-1079
- 11-digit product format
- 500901079
- Labeler code
- 50090
- Product ID
- 50090-1079_b4b91386-63c2-4000-9f7a-353ae9146701
- Type
- VACCINE
- Nonproprietary name
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- BLA125111
- Marketing category
- BLA
- Marketing start
- 2005-06-10
- Substance
- BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 5; 5; 3; 2.5; 5; 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [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
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) | 5 ug/.5mL |
| BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN | 5 ug/.5mL |
| BORDETELLA PERTUSSIS PERTACTIN ANTIGEN | 3 ug/.5mL |
| BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) | 2.5 ug/.5mL |
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 5 [Lf]/.5mL |
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 2 [Lf]/.5mL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1079-0 | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (F | 10 in 1 PACKAGE | INJECTION, SUSPENSION | 10 | | 14 |
| 50090-1079-1 | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (F | .5 mL in 1 VIAL | INJECTION, SUSPENSION | .5 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1079 | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, AND BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250516_1d8930f5-434d-4bfa-befc-b54913c8dd36.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1300205 | Tdap (generic for Adacel) 0.5 ML Injection | PSN | 1d8930f5-434d-4bfa-befc-b54913c8dd36 | 14 |
| 1300205 | 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.005 MG/ML / diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection | SCD | 1d8930f5-434d-4bfa-befc-b54913c8dd36 | 14 |
| 1300205 | Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 5 MCG / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 5 MCG / Bordetella pertussis pertactin vaccine, inactivated 3 MCG / Bordetella pertussis toxoid vaccine, inactivated 2.5 MCG / diphtheria toxoid vaccine 2 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection | SY | 1d8930f5-434d-4bfa-befc-b54913c8dd36 | 14 |
| 1300205 | Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2 UNT / acellular pertussis vaccine, inactivated 15.5 MCG) per 0.5 ML Injection | SY | 1d8930f5-434d-4bfa-befc-b54913c8dd36 | 14 |
| 1300205 | tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (generic for Adacel) 0.5 ML Injection | SY | 1d8930f5-434d-4bfa-befc-b54913c8dd36 | 14 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-1079-0 | 50090107900 | 10 VIAL in 1 PACKAGE (50090-1079-0) / .5 mL in 1 VIAL (50090-1079-1) | 10 vial | 2005-06-10 | No | No | Historical |
| 50090-1079-1 | 50090107901 | .5 mL in 1 VIAL | | | | | Historical |