bimzelx

Generic: bimekizumab

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

Drug Facts

Product Profile

Brand Name bimzelx
Generic Name bimekizumab
Labeler ucb, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

bimekizumab 160 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-780
Product ID 50474-780_37b310bd-f6a0-9d4e-e063-6294a90a889d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761151
Listing Expiration 2026-12-31
Marketing Start 2023-10-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474780
Hyphenated Format 50474-780

Supplemental Identifiers

RxCUI
2668086 2668093 2668099 2668103 2699121 2699122 2699123 2699124
UNII
09495UIM6V

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 bimzelx (source: ndc)
Generic Name bimekizumab (source: ndc)
Application Number BLA761151 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 160 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (50474-780-78) / 1 mL in 1 SYRINGE, GLASS
  • 2 SYRINGE, GLASS in 1 CARTON (50474-780-79) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

50474-780-78 1 SYRINGE, GLASS in 1 CARTON (50474-780-78) / 1 mL in 1 SYRINGE, GLASS 50474-780-79 2 SYRINGE, GLASS in 1 CARTON (50474-780-79) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

bimekizumab (160 mg/mL)

Linked Drug Pages (1)

Bimzelx ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "37b310bd-f6a0-9d4e-e063-6294a90a889d", "openfda": {"unii": ["09495UIM6V"], "rxcui": ["2668086", "2668093", "2668099", "2668103", "2699121", "2699122", "2699123", "2699124"], "spl_set_id": ["26b88358-871f-4c80-9d80-b2fb16477f81"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (50474-780-78)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "50474-780-78", "marketing_start_date": "20241001"}, {"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (50474-780-79)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "50474-780-79", "marketing_start_date": "20231017"}], "brand_name": "Bimzelx", "product_id": "50474-780_37b310bd-f6a0-9d4e-e063-6294a90a889d", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "50474-780", "generic_name": "bimekizumab", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bimzelx", "active_ingredients": [{"name": "BIMEKIZUMAB", "strength": "160 mg/mL"}], "application_number": "BLA761151", "marketing_category": "BLA", "marketing_start_date": "20231017", "listing_expiration_date": "20261231"}