idacio

Generic: adalimumab-aacf

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name idacio
Generic Name adalimumab-aacf
Labeler fresenius kabi usa, llc
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-554
Product ID 65219-554_f286c1d4-a9f6-45dd-a8a4-c0065e1a51d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761255
Listing Expiration 2027-12-31
Marketing Start 2023-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219554
Hyphenated Format 65219-554

Supplemental Identifiers

RxCUI
797544 2640851 2640857 2640859 2640862 2640864 2640865 2640869 2640870

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 idacio (source: ndc)
Generic Name adalimumab-aacf (source: ndc)
Application Number BLA761255 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/0.8 ml
  • 1 ml
source: label
Packaging
  • 2 KIT in 1 CARTON (65219-554-28) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95)
  • 3 KIT in 1 CARTON (65219-554-38) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95)
source: ndc

Packages (2)

65219-554-28 2 KIT in 1 CARTON (65219-554-28) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) 65219-554-38 3 KIT in 1 CARTON (65219-554-38) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Idacio ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "f286c1d4-a9f6-45dd-a8a4-c0065e1a51d6", "openfda": {"rxcui": ["797544", "2640851", "2640857", "2640859", "2640862", "2640864", "2640865", "2640869", "2640870"], "spl_set_id": ["43de75ac-1a37-4609-9edd-68bda2448a47"], "manufacturer_name": ["Fresenius Kabi USA, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 KIT in 1 CARTON (65219-554-28)  / 1 KIT in 1 KIT *  .8 mL in 1 SYRINGE, GLASS (65219-574-04)  *  1 SWAB in 1 POUCH (65219-332-95)", "package_ndc": "65219-554-28", "marketing_start_date": "20230701"}, {"sample": false, "description": "3 KIT in 1 CARTON (65219-554-38)  / 1 KIT in 1 KIT *  .8 mL in 1 SYRINGE, GLASS (65219-574-04)  *  1 SWAB in 1 POUCH (65219-332-95)", "package_ndc": "65219-554-38", "marketing_start_date": "20230701"}], "brand_name": "Idacio", "product_id": "65219-554_f286c1d4-a9f6-45dd-a8a4-c0065e1a51d6", "dosage_form": "KIT", "product_ndc": "65219-554", "generic_name": "adalimumab-aacf", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Idacio", "application_number": "BLA761255", "marketing_category": "BLA", "marketing_start_date": "20230701", "listing_expiration_date": "20271231"}