Cyltezo

Generic: adalimumab-adbm

Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Active

Drug Facts

Product Profile

Brand Name Cyltezo
Generic Name adalimumab-adbm
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Dosage Form KIT

Identifiers & Regulatory

Product NDC 0597-0495
Product ID 0597-0495_c89d075c-8ade-4d17-970e-dc683803056b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761058
Listing Expiration 2026-12-31
Marketing Start 2024-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970495
Hyphenated Format 0597-0495

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 Cyltezo (source: ndc)
Generic Name adalimumab-adbm (source: ndc)
Application Number BLA761058 (source: ndc)

Resolved Composition

Strengths
  • 40 mg/0.8 ml
  • 40 mg/0.4 ml
  • 20 mg/0.4 ml
  • 10 mg/0.2 ml
  • 1 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (0597-0495-47) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0490-32) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (0597-0495-50) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0490-32) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET
source: ndc

Packages (2)

0597-0495-47 1 KIT in 1 CARTON (0597-0495-47) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0490-32) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET 0597-0495-50 2 KIT in 1 CARTON (0597-0495-50) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0490-32) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cyltezo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "c89d075c-8ade-4d17-970e-dc683803056b", "openfda": {"rxcui": ["797544", "2640883", "2640889", "2640891", "2640892", "2640893", "2640894", "2640895", "2640898", "2640900", "2640901", "2640902", "2640903", "2680743", "2680746", "2680748", "2680750", "2680756", "2680757", "2680759", "2680760"], "spl_set_id": ["115ea79b-7209-7f19-b35d-36ec0828fbf5"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (0597-0495-47)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0490-32)  / .4 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET", "package_ndc": "0597-0495-47", "marketing_start_date": "20240430"}, {"sample": false, "description": "2 KIT in 1 CARTON (0597-0495-50)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (0597-0490-32)  / .4 mL in 1 SYRINGE *  2 PACKET in 1 TRAY / 1 mL in 1 PACKET", "package_ndc": "0597-0495-50", "marketing_start_date": "20240430"}], "brand_name": "Cyltezo", "product_id": "0597-0495_c89d075c-8ade-4d17-970e-dc683803056b", "dosage_form": "KIT", "product_ndc": "0597-0495", "generic_name": "adalimumab-adbm", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyltezo", "application_number": "BLA761058", "marketing_category": "BLA", "marketing_start_date": "20240430", "listing_expiration_date": "20261231"}