Vaccine · BLA
Daptacel NDC 49281-286
Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 15 [Lf]/.5mL + 5 more ingredients · Injection, Suspension · Intramuscular · Sanofi Vaccines US Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49281-286-01 | 49281028601 | 1 VIAL in 1 PACKAGE (49281-286-01) / .5 mL in 1 VIAL (49281-286-58)Marketed from May 14, 2002 | |
| 49281-286-05 | 49281028605 | 5 VIAL in 1 PACKAGE (49281-286-05) / .5 mL in 1 VIAL (49281-286-58)Marketed from May 14, 2002 | |
| 49281-286-10 | 49281028610 | 10 VIAL in 1 PACKAGE (49281-286-10) / .5 mL in 1 VIAL (49281-286-58)Marketed from May 14, 2002 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Daptacel
- Generic name (nonproprietary)
- 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
- Active ingredients
- Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) — 15 [Lf]/.5mLClostridium tetani toxoid antigen (Formaldehyde inactivated) — 5 [Lf]/.5mLBordetella pertussis toxoid antigen (Glutaraldehyde inactivated) — 10 ug/.5mLBordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated) — 5 ug/.5mLBordetella pertussis pertactin antigen — 3 ug/.5mLBordetella pertussis fimbriae 2/3 antigen — 5 ug/.5mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- Sanofi Vaccines US Inc.
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103666
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Diphtheria Toxoid (Chemical structure)Pertussis Vaccine (Chemical structure)Pertussis Vaccine (Chemical structure)Pertussis Vaccine (Chemical structure)Tetanus Toxoid (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
- Identifiers
- Product ID 49281-286_73caea6f-276f-4e9f-967c-7bf522b68ba1SPL ID 73caea6f-276f-4e9f-967c-7bf522b68ba1
- Pharmacologic class
- Inactivated Bordetella Pertussis Vaccine; Inactivated Clostridium Tetani Vaccine; Inactivated Corynebacterium Diphtheriae Vaccine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N449281028601followed by a unit qualifier and the quantityPackage 49281-0286-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.