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 KIT
Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-700
Product ID 50474-700_4b984e6f-72ac-4fdc-e063-6394a90af105
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125160
Listing Expiration 2027-12-31
Marketing Start 2008-04-20

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 50474700
Hyphenated Format 50474-700

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: label

Resolved Composition

Strengths
  • 200 mg
  • 200 mg/ml
  • 1 ml
  • 3 ml
source: label
Packaging
  • 2 KIT in 1 CARTON (50474-700-61) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS
  • 2 KIT in 1 CARTON (50474-700-62) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

50474-700-61 2 KIT in 1 CARTON (50474-700-61) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS 50474-700-62 2 KIT in 1 CARTON (50474-700-62) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cimzia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": true, "description": "2 KIT in 1 CARTON (50474-700-61)  / 1 KIT in 1 KIT *  1 mL in 1 VIAL, GLASS *  1 mL in 1 VIAL, GLASS", "package_ndc": "50474-700-61", "marketing_start_date": "20080420"}, {"sample": false, "description": "2 KIT in 1 CARTON (50474-700-62)  / 1 KIT in 1 KIT *  1 mL in 1 VIAL, GLASS *  1 mL in 1 VIAL, GLASS", "package_ndc": "50474-700-62", "marketing_start_date": "20080420"}], "brand_name": "Cimzia", "product_id": "50474-700_4b984e6f-72ac-4fdc-e063-6394a90af105", "dosage_form": "KIT", "product_ndc": "50474-700", "generic_name": "certolizumab pegol", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cimzia", "application_number": "BLA125160", "marketing_category": "BLA", "marketing_start_date": "20080420", "listing_expiration_date": "20271231"}