humira

Generic: adalimumab

Labeler: cordavis limited
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name humira
Generic Name adalimumab
Labeler cordavis limited
Dosage Form KIT
Manufacturer
Cordavis Limited

Identifiers & Regulatory

Product NDC 83457-817
Product ID 83457-817_5fe81b1a-cc31-444e-a0f1-1ea4f7334b89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125057
Listing Expiration 2027-12-31
Marketing Start 2024-02-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83457817
Hyphenated Format 83457-817

Supplemental Identifiers

RxCUI
797544 1726844 1726846 1872979 1872980 1921009 1921010 1921016 1921017 1921238 1921240

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 humira (source: ndc)
Generic Name adalimumab (source: ndc)
Application Number BLA125057 (source: ndc)

Resolved Composition

Strengths
  • 80 mg/0.8 ml
  • 40 mg/0.8 ml
  • 40 mg/0.4 ml
  • 20 mg/0.4 ml
  • 20 mg/0.2 ml
  • 10 mg/0.2 ml
  • 10 mg/0.1 ml
  • 1 ml
source: label
Packaging
  • 2 KIT in 1 CARTON (83457-817-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-816-01) / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01)
source: ndc

Packages (1)

83457-817-02 2 KIT in 1 CARTON (83457-817-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-816-01) / .1 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Humira ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "openfda": {"rxcui": ["797544", "1726844", "1726846", "1872979", "1872980", "1921009", "1921010", "1921016", "1921017", "1921238", "1921240"], "spl_set_id": ["4977567e-3525-44ac-9ff5-f1e74b053950"], "manufacturer_name": ["Cordavis Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 KIT in 1 CARTON (83457-817-02)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY (83457-816-01)  / .1 mL in 1 SYRINGE *  1 mL in 1 PACKET (83457-927-01)", "package_ndc": "83457-817-02", "marketing_start_date": "20240214"}], "brand_name": "Humira", "product_id": "83457-817_5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "dosage_form": "KIT", "product_ndc": "83457-817", "generic_name": "Adalimumab", "labeler_name": "Cordavis Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Humira", "application_number": "BLA125057", "marketing_category": "BLA", "marketing_start_date": "20240214", "listing_expiration_date": "20271231"}