What is NDC 58160-811?

58160-811 is the product NDC for Pediarix, Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL + 8 more ingredients injection, suspension, listed with the FDA by GlaxoSmithKline Biologicals SA. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined).

What is the active ingredient?

Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated), Clostridium tetani toxoid antigen (Formaldehyde inactivated), Bordetella pertussis toxoid antigen (Formaldehyde, Glutaraldehyde inactivated), Bordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated), Bordetella pertussis pertactin antigen (Formaldehyde inactivated), Hepatitis b virus subtype adw2 hbsag surface protein antigen, Poliovirus type 1 antigen (Formaldehyde inactivated), Poliovirus type 2 antigen (Formaldehyde inactivated), Poliovirus type 3 antigen (Formaldehyde inactivated).

GlaxoSmithKline Biologicals SA, NDC labeler code 58160. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pediarix?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pediarix NDC 58160-811 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0811Add 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
58160-811-52	5816008115258160081152	10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43)Marketed from Jul 24, 2009

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): Pediarix
Generic name (nonproprietary): diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine combined
Active ingredients: Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) — 25 [iU]/.5mLClostridium tetani toxoid antigen (Formaldehyde inactivated) — 10 [iU]/.5mLBordetella pertussis toxoid antigen (Formaldehyde, Glutaraldehyde inactivated) — 25 ug/.5mLBordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated) — 25 ug/.5mLBordetella pertussis pertactin antigen (Formaldehyde inactivated) — 8 ug/.5mLHepatitis b virus subtype adw2 hbsag surface protein antigen — 10 ug/.5mLPoliovirus type 1 antigen (Formaldehyde inactivated) — 40 [iU]/.5mLPoliovirus type 2 antigen (Formaldehyde inactivated) — 8 [iU]/.5mLPoliovirus type 3 antigen (Formaldehyde inactivated) — 32 [iU]/.5mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 103907
Marketing start: Jul 24, 2009
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)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)Poliovirus Vaccines (Chemical structure)Poliovirus Vaccines (Chemical structure)Poliovirus Vaccines (Chemical structure)Tetanus Toxoid (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
Identifiers: Product ID 58160-811_97c7ea5c-c93e-4bba-9f03-b0e88ed68439SPL ID 97c7ea5c-c93e-4bba-9f03-b0e88ed68439
Pharmacologic class: Inactivated Bordetella Pertussis Vaccine; Inactivated Clostridium Tetani Vaccine; Inactivated Corynebacterium Diphtheriae Vaccine; Inactivated Poliovirus 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

N458160081152 followed by a unit qualifier and the quantity

Package 58160-0811-52. 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 58160-811

What is NDC 58160-811?: 58160-811 is the product NDC for Pediarix, Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL + 8 more ingredients injection, suspension, listed with the FDA by GlaxoSmithKline Biologicals SA. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined).
What is the active ingredient?: Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated), Clostridium tetani toxoid antigen (Formaldehyde inactivated), Bordetella pertussis toxoid antigen (Formaldehyde, Glutaraldehyde inactivated), Bordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated), Bordetella pertussis pertactin antigen (Formaldehyde inactivated), Hepatitis b virus subtype adw2 hbsag surface protein antigen, Poliovirus type 1 antigen (Formaldehyde inactivated), Poliovirus type 2 antigen (Formaldehyde inactivated), Poliovirus type 3 antigen (Formaldehyde inactivated).
Who is the labeler?: GlaxoSmithKline Biologicals SA, NDC labeler code 58160. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pediarix?: 1 other product NDC are listed under this name. See all Pediarix 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 Pediarix NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pediarixdiphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine combined	Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL + 8 more ingredients	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-7541	50090-7541-00

Other NDCs under BLA 103907

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

FDA NDC Directory listings under BLA 103907
Product	Strength	Form · route	Labeler	Product NDC
Pediarixdiphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine combined	Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL + 8 more ingredients	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-7541