Tenivac NDC 49281-215

NDC codes

FDA NDC Directory

Product NDC (as listed)49281-215Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49281-0215Add 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
49281-215-10	49281021510	10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58)Marketed from Dec 8, 2010
49281-215-15	49281021515	10 SYRINGE in 1 PACKAGE (49281-215-15) / .5 mL in 1 SYRINGE (49281-215-88)Marketed from Dec 8, 2010

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): Tenivac
Generic name (nonproprietary): clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)
Active ingredients: Clostridium tetani toxoid antigen (Formaldehyde inactivated) — 5 [Lf]/.5mLCorynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) — 2 [Lf]/.5mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: Sanofi Vaccines US Inc.
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 103171
Marketing start: Dec 8, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Diphtheria Toxoid (Chemical structure)Tetanus Toxoid (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
Identifiers: Product ID 49281-215_5c42402c-4757-4453-ab70-76ea3490b1c0SPL ID 5c42402c-4757-4453-ab70-76ea3490b1c0
Pharmacologic class: 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

N449281021510 followed by a unit qualifier and the quantity

Package 49281-0215-10. 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.

Other NDCs under BLA 103171

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

FDA NDC Directory listings under BLA 103171
Product	Strength	Form · route	Labeler	Product NDC
Tenivacclostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)	Clostridium tetani toxoid antigen (Formaldehyde inactivated) 5 [Lf]/.5mL; Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 2 [Lf]/.5mL	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-2062