Prescription drug · BLA
Cimzia (Certolizumab pegol) NDC 50474-710
Certolizumab pegol 200 mg/mL · Injection, Solution · Subcutaneous · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50474-710-79 | 5047407107950474071079 | 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASSMarketed from May 14, 2009 | |
| 50474-710-80 | 5047407108050474071080 | 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASSMarketed from May 14, 2009 · Sample package | |
| 50474-710-81 | 5047407108150474071081 | 3 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.NDC labeler code 50474
- 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
- Pharmacologic class
- Tumor Necrosis Factor Blocker
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.
- NDC on a medical claim
N450474071079followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult patients with active psoriatic arthritis. ( 1.4 ) Treatment of adults with active ankylosing spondylitis ( 1.5 ) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs o…
Excerpt only. Read the full label for complete information.
About NDC 50474-710
- What is NDC 50474-710?
- 50474-710 is the product NDC for Cimzia (certolizumab pegol), Certolizumab pegol 200 mg/mL injection, solution, listed with the FDA by UCB, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cimzia (Certolizumab pegol).
- What is the active ingredient?
- Certolizumab pegol.
- Who is the labeler?
- UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cimzia?
- 2 other product NDCs are listed under this name. See all Cimzia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cimzia products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under BLA 125160
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.