adalimumab

Generic: adalimumab-fkjp

Labeler: biocon biologics inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name adalimumab
Generic Name adalimumab-fkjp
Labeler biocon biologics inc
Dosage Form KIT
Manufacturer
Biocon Biologics Inc

Identifiers & Regulatory

Product NDC 83257-021
Product ID 83257-021_ce598802-5148-0115-bd4c-fea7dd51fb90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761154
Listing Expiration 2027-12-31
Marketing Start 2024-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83257021
Hyphenated Format 83257-021

Supplemental Identifiers

RxCUI
797544 2640404 2640412 2640417

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 adalimumab (source: ndc)
Generic Name adalimumab-fkjp (source: ndc)
Application Number BLA761154 (source: ndc)

Resolved Composition

Strengths
  • 40 mg/0.8 ml
  • 20 mg/0.4 ml
  • 1 ml
source: label
Packaging
  • 2 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET
source: ndc

Packages (1)

83257-021-42 2 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Adalimumab ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ce598802-5148-0115-bd4c-fea7dd51fb90", "openfda": {"rxcui": ["797544", "2640404", "2640412", "2640417"], "spl_set_id": ["5cde907d-6747-0e62-db25-1718ee717fe7"], "manufacturer_name": ["Biocon Biologics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 KIT (83257-021-42)  / 1 KIT in 1 TRAY *  2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE *  2 PACKET in 1 KIT / 1 mL in 1 PACKET", "package_ndc": "83257-021-42", "marketing_start_date": "20240415"}], "brand_name": "Adalimumab", "product_id": "83257-021_ce598802-5148-0115-bd4c-fea7dd51fb90", "dosage_form": "KIT", "product_ndc": "83257-021", "generic_name": "adalimumab-fkjp", "labeler_name": "Biocon Biologics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adalimumab", "application_number": "BLA761154", "marketing_category": "BLA", "marketing_start_date": "20240415", "listing_expiration_date": "20271231"}