What is NDC 49281-400?

49281-400 is the product NDC for Adacel TDaP, Clostridium tetani toxoid antigen (Formaldehyde inactivated) 5 [Lf]/.5mL + 5 more ingredients injection, suspension, listed with the FDA by Sanofi Vaccines US Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Adacel TDaP (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).

What is the active ingredient?

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, Bordetella pertussis fimbriae 2/3 antigen.

Sanofi Vaccines US Inc., NDC labeler code 49281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Adacel TDaP?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Adacel TDaP NDC 49281-400 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49281-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49281-0400Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
49281-400-10	4928104001049281040010	10 VIAL in 1 PACKAGE (49281-400-10) / .5 mL in 1 VIAL (49281-400-58)Marketed from Jun 10, 2005
49281-400-20	4928104002049281040020	5 SYRINGE in 1 PACKAGE (49281-400-20) / .5 mL in 1 SYRINGE (49281-400-89)Marketed from Jun 10, 2005

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): Adacel TDaPSuffix: TDaP
Generic name (nonproprietary): 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
Active ingredients: Clostridium tetani toxoid antigen (Formaldehyde inactivated) — 5 [Lf]/.5mLCorynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) — 2 [Lf]/.5mLBordetella pertussis toxoid antigen (Glutaraldehyde inactivated) — 2.5 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.NDC labeler code 49281
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125111
Marketing start: Jun 10, 2005
Listing expires: Dec 31, 2027
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 49281-400_9dfc5925-3f9a-495f-bcd1-02d8ba2e70e1SPL ID 9dfc5925-3f9a-495f-bcd1-02d8ba2e70e1
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.

How CPT relates to drug billing

NDC on a medical claim

N449281040010 followed by a unit qualifier and the quantity

Package 49281-0400-10. 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.

About NDC 49281-400

What is NDC 49281-400?: 49281-400 is the product NDC for Adacel TDaP, Clostridium tetani toxoid antigen (Formaldehyde inactivated) 5 [Lf]/.5mL + 5 more ingredients injection, suspension, listed with the FDA by Sanofi Vaccines US Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Adacel TDaP (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).
What is the active ingredient?: 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, Bordetella pertussis fimbriae 2/3 antigen.
Who is the labeler?: Sanofi Vaccines US Inc., NDC labeler code 49281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Adacel TDaP?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under BLA 125111

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125111
Product	Strength	Form · route	Labeler	Product NDC
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	Clostridium tetani toxoid antigen (Formaldehyde inactivated) 5 [Lf]/.5mL + 5 more ingredients	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-1079