adalimumab

Generic: adalimumab-aaty

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

Drug Facts

Product Profile

Brand Name adalimumab
Generic Name adalimumab-aaty
Labeler celltrion usa, inc.
Dosage Form KIT
Manufacturer
CELLTRION USA, Inc.

Identifiers & Regulatory

Product NDC 72606-022
Product ID 72606-022_68fa51bf-22b5-4963-bc1c-9be00fb09b2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761219
Listing Expiration 2026-12-31
Marketing Start 2023-11-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72606022
Hyphenated Format 72606-022

Supplemental Identifiers

RxCUI
797544 2639651 2639659 2668483 2668485 2668487 2668489

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-aaty (source: ndc)
Application Number BLA761219 (source: ndc)

Resolved Composition

Strengths
  • 80 mg/0.8 ml
  • 40 mg/0.4 ml
  • 20 mg/0.2 ml
  • 1 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72606-022-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (72606-022-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 4 KIT in 1 CARTON (72606-022-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 6 KIT in 1 CARTON (72606-022-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 1 KIT in 1 CARTON (72606-022-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (72606-022-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 4 KIT in 1 CARTON (72606-022-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 6 KIT in 1 CARTON (72606-022-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 1 KIT in 1 CARTON (72606-022-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (72606-022-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 4 KIT in 1 CARTON (72606-022-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 6 KIT in 1 CARTON (72606-022-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET
source: ndc

Packages (12)

72606-022-01 1 KIT in 1 CARTON (72606-022-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-02 2 KIT in 1 CARTON (72606-022-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-03 4 KIT in 1 CARTON (72606-022-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-04 6 KIT in 1 CARTON (72606-022-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-05 1 KIT in 1 CARTON (72606-022-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-06 2 KIT in 1 CARTON (72606-022-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-07 4 KIT in 1 CARTON (72606-022-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-08 6 KIT in 1 CARTON (72606-022-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-09 1 KIT in 1 CARTON (72606-022-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-10 2 KIT in 1 CARTON (72606-022-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-11 4 KIT in 1 CARTON (72606-022-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-022-12 6 KIT in 1 CARTON (72606-022-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE * 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": "68fa51bf-22b5-4963-bc1c-9be00fb09b2a", "openfda": {"rxcui": ["797544", "2639651", "2639659", "2668483", "2668485", "2668487", "2668489"], "spl_set_id": ["c44365e9-d470-4e35-978d-8565a9e3471e"], "manufacturer_name": ["CELLTRION USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72606-022-01)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-01", "marketing_start_date": "20231130"}, {"sample": false, "description": "2 KIT in 1 CARTON (72606-022-02)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-02", "marketing_start_date": "20231130"}, {"sample": false, "description": "4 KIT in 1 CARTON (72606-022-03)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-03", "marketing_start_date": "20231130"}, {"sample": false, "description": "6 KIT in 1 CARTON (72606-022-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-04", "marketing_start_date": "20231130"}, {"sample": false, "description": "1 KIT in 1 CARTON (72606-022-05)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-05", "marketing_start_date": "20231130"}, {"sample": false, "description": "2 KIT in 1 CARTON (72606-022-06)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-06", "marketing_start_date": "20231130"}, {"sample": false, "description": "4 KIT in 1 CARTON (72606-022-07)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-07", "marketing_start_date": "20231130"}, {"sample": false, "description": "6 KIT in 1 CARTON (72606-022-08)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-08", "marketing_start_date": "20231130"}, {"sample": false, "description": "1 KIT in 1 CARTON (72606-022-09)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-09", "marketing_start_date": "20231130"}, {"sample": false, "description": "2 KIT in 1 CARTON (72606-022-10)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-10", "marketing_start_date": "20231130"}, {"sample": false, "description": "4 KIT in 1 CARTON (72606-022-11)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-11", "marketing_start_date": "20231130"}, {"sample": false, "description": "6 KIT in 1 CARTON (72606-022-12)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-022-12", "marketing_start_date": "20231130"}], "brand_name": "Adalimumab", "product_id": "72606-022_68fa51bf-22b5-4963-bc1c-9be00fb09b2a", "dosage_form": "KIT", "product_ndc": "72606-022", "generic_name": "adalimumab-aaty", "labeler_name": "CELLTRION USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adalimumab", "application_number": "BLA761219", "marketing_category": "BLA", "marketing_start_date": "20231130", "listing_expiration_date": "20261231"}