cyltezo

Generic: adalimumab-adbm

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name cyltezo
Generic Name adalimumab-adbm
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0495
Product ID 0597-0495_72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761058
Listing Expiration 2027-12-31
Marketing Start 2024-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970495
Hyphenated Format 0597-0495

Supplemental Identifiers

RxCUI
797544 2640883 2640889 2640891 2640892 2640893 2640894 2640895 2640898 2640900 2640901 2640902 2640903 2680743 2680746 2680748 2680750 2680756 2680757 2680759 2680760

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 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
  • 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 (1)

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": "72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3", "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": "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_72dd9ccf-66f7-47a4-b6e4-4bb2f9a1caa3", "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": "20271231"}