DAPTACEL
- Product NDC
- 49281-286
- 11-digit product format
- 492810286
- Labeler code
- 49281
- Product ID
- 49281-286_194ddcca-4dea-4540-9a2e-aba2d5a8c823
- Type
- VACCINE
- Nonproprietary name
- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani 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
- Sanofi Vaccines US Inc.
- Application
- BLA103666
- Marketing category
- BLA
- Marketing start
- 2002-05-14
- 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; 10; 5; 15 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DAPTACEL
- Listing expiration
- 2027-12-31
Active Ingredients#
| 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) | 10 ug/.5mL |
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 5 [Lf]/.5mL |
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 [Lf]/.5mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49281-286-01 | DAPTACEL | 1 in 1 PACKAGE | INJECTION, SUSPENSION | 1 | 17 | |
| 49281-286-05 | DAPTACEL | 5 in 1 PACKAGE | INJECTION, SUSPENSION | 5 | 17 | |
| 49281-286-10 | DAPTACEL | 10 in 1 PACKAGE | INJECTION, SUSPENSION | 10 | 17 | |
| 49281-286-58 | DAPTACEL | 0.5 mL in 1 VIAL | INJECTION, SUSPENSION | 0.5 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49281-286-10 | ML - Milliliter | 49281-286 | 05bd9677-3a24-49e7-b7e9-ca446331b789 | 1 | 2013-02-13 |
| 49281-286-58 | ML - Milliliter | 49281-286 | e6d6475a-1e25-4770-8b21-fb066ceab9d2 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49281-286 | DAPTACEL (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CLOSTRIDIUM TETANI 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 [SANOFI PASTEUR INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20250323_06f34d0f-4e72-41d3-967f-8abf3f2005c1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1300310 | DAPTACEL vaccine 0.5 ML Injection | PSN | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300308 | DTaP (generic for Daptacel) 0.5 ML Injection | PSN | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300310 | 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 0.02 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Daptacel] | SBD | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300308 | 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 0.02 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection | SCD | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300308 | 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 10 MCG / diphtheria toxoid vaccine 15 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection | SY | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300310 | Daptacel (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 10 MCG / Diphtheria Toxoid Vaccine 15 UNT / Tetanus Toxoid Vaccine 5 UNT) per 0.5 ML Injection | SY | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300310 | Daptacel DTaP (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) Injection | SY | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300308 | diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP generic for Daptacel) 0.5 ML Injection | SY | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
| 1300308 | DTaP (diphtheria toxoid vaccine, inactivated 15 UNT / tetanus toxoid vaccine, inactivated 5 UNT / acellular pertussis vaccine, inactivated 23 MCG) per 0.5 ML Injection | SY | 06f34d0f-4e72-41d3-967f-8abf3f2005c1 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49281-286-01 | 49281028601 | 1 VIAL in 1 PACKAGE (49281-286-01) / .5 mL in 1 VIAL (49281-286-58) | 1 vial | 2002-05-14 | 0000-00-00 | No | No | Current |
| 49281-286-05 | 49281028605 | 5 VIAL in 1 PACKAGE (49281-286-05) / .5 mL in 1 VIAL (49281-286-58) | 5 vial | 2002-05-14 | 0000-00-00 | No | No | Current |
| 49281-286-10 | 49281028610 | 10 VIAL in 1 PACKAGE (49281-286-10) / .5 mL in 1 VIAL (49281-286-58) | 10 vial | 2002-05-14 | 0000-00-00 | No | No | Current |
| 49281-286-58 | 49281028658 | 0.5 mL in 1 VIAL | 0.5 ml | Historical |