Pediarix NDC 50090-7541

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7541Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7541Add 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
50090-7541-0	50090754100	10 SYRINGE in 1 CARTON (50090-7541-0) / .5 mL in 1 SYRINGE (50090-7541-1)Marketed from Jul 24, 2009

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: A-S Medication Solutions
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 50090-7541_479d4986-8756-4316-ba84-5ef27a8ec54bSPL ID 479d4986-8756-4316-ba84-5ef27a8ec54b
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

N450090754100 followed by a unit qualifier and the quantity

Package 50090-7541-00. 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 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	GlaxoSmithKline Biologicals SA	58160-811