NDC codes

FDA NDC Directory
Product NDC (as listed)50474-710Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50474-0710Add 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 NDC11-digit (billing)PackageCopy
50474-710-79504740710792 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASSMarketed from May 14, 2009
50474-710-80504740710802 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASSMarketed from May 14, 2009 · Sample package
50474-710-81504740710813 CARTON in 1 BOX (50474-710-81) / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASSMarketed from May 14, 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)
Cimzia
Generic name (nonproprietary)
certolizumab pegol
Active ingredients
Certolizumab pegol — 200 mg/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
UCB, Inc.
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125160
Marketing start
Listing expires
Other FDA classes
Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers
Product ID 50474-710_4b984e6f-72ac-4fdc-e063-6394a90af105SPL ID 4b984e6f-72ac-4fdc-e063-6394a90af105SPL set ID b4c2c9dc-a0bb-4d64-a667-a67ebe88392dRxCUI 795081, 795085, 849597, 849599, 2724369, 2724370, 2724371, 2724372UNII UMD07X179E

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

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N450474071079 followed by a unit qualifier and the quantity

Package 50474-0710-79. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under BLA 125160

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

FDA NDC Directory listings under BLA 125160
ProductStrengthForm · routeLabelerProduct NDC
Cimziacertolizumab pegol—KitUCB, Inc.50474-700
Cimziacertolizumab pegolCertolizumab pegol 200 mg/mLInjection, SolutionSubcutaneousUCB, Inc.50474-750

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