What is NDC 49281-511?

49281-511 is the product NDC for Pentacel kit, listed with the FDA by Sanofi Vaccines US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Pentacel (Diphtheria and tetanus toxoids and acellular pertussis adsorbed, Inactivated poliovirus and haemophilus b conjugate (Tetanus toxoid conjugate) vaccine).

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 Pentacel?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pentacel NDC 49281-511 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49281-511Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49281-0511Add 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
49281-511-05	49281051105	1 KIT in 1 PACKAGE (49281-511-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58)Marketed from Jun 20, 2008

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): Pentacel
Generic name (nonproprietary): diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine
Dosage form: Kit
Labeler: Sanofi Vaccines US Inc.NDC labeler code 49281
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125145
Marketing start: Jun 20, 2008
Listing expires: Dec 31, 2027
Identifiers: Product ID 49281-511_2bddb5e4-99aa-49c6-9e9d-719e87c1ad22SPL ID 2bddb5e4-99aa-49c6-9e9d-719e87c1ad22

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

N449281051105 followed by a unit qualifier and the quantity

Package 49281-0511-05. 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 49281-511

What is NDC 49281-511?: 49281-511 is the product NDC for Pentacel kit, listed with the FDA by Sanofi Vaccines US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pentacel (Diphtheria and tetanus toxoids and acellular pertussis adsorbed, Inactivated poliovirus and haemophilus b conjugate (Tetanus toxoid conjugate) vaccine).
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 Pentacel?: 1 other product NDC are listed under this name. See all Pentacel NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pentacel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pentaceldiphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine	—	Kit	A-S Medication Solutions	50090-7544	50090-7544-00

Other NDCs under BLA 125145

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

FDA NDC Directory listings under BLA 125145
Product	Strength	Form · route	Labeler	Product NDC
Pentaceldiphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine	—	Kit	A-S Medication Solutions	50090-7544