cimzia

Generic: certolizumab pegol

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name cimzia
Generic Name certolizumab pegol
Labeler ucb, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

certolizumab pegol 200 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-710
Product ID 50474-710_4b984e6f-72ac-4fdc-e063-6394a90af105
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125160
Listing Expiration 2027-12-31
Marketing Start 2009-05-14

Pharmacologic Class

Established (EPC)
tumor necrosis factor blocker [epc]
Mechanism of Action
tumor necrosis factor receptor blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474710
Hyphenated Format 50474-710

Supplemental Identifiers

RxCUI
795081 795085 849597 849599 2724369 2724370 2724371 2724372
UNII
UMD07X179E
NUI
N0000175610 N0000175451

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cimzia (source: ndc)
Generic Name certolizumab pegol (source: ndc)
Application Number BLA125160 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASS
  • 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASS
  • 3 CARTON in 1 BOX (50474-710-81) / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (3)

50474-710-79 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASS 50474-710-80 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASS 50474-710-81 3 CARTON in 1 BOX (50474-710-81) / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

certolizumab pegol (200 mg/mL)

Linked Drug Pages (1)

Cimzia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4b984e6f-72ac-4fdc-e063-6394a90af105", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["UMD07X179E"], "rxcui": ["795081", "795085", "849597", "849599", "2724369", "2724370", "2724371", "2724372"], "spl_set_id": ["b4c2c9dc-a0bb-4d64-a667-a67ebe88392d"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (50474-710-79)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "50474-710-79", "marketing_start_date": "20090514"}, {"sample": true, "description": "2 SYRINGE, GLASS in 1 CARTON (50474-710-80)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "50474-710-80", "marketing_start_date": "20090514"}, {"sample": false, "description": "3 CARTON in 1 BOX (50474-710-81)  / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "50474-710-81", "marketing_start_date": "20090514"}], "brand_name": "Cimzia", "product_id": "50474-710_4b984e6f-72ac-4fdc-e063-6394a90af105", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "50474-710", "generic_name": "certolizumab pegol", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimzia", "active_ingredients": [{"name": "CERTOLIZUMAB PEGOL", "strength": "200 mg/mL"}], "application_number": "BLA125160", "marketing_category": "BLA", "marketing_start_date": "20090514", "listing_expiration_date": "20271231"}