adalimumab-aacf

Generic: adalimumab

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 65219-612
Product ID 65219-612_ed59e023-eb91-482f-a1fe-19a31c0906c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761255
Listing Expiration 2027-12-31
Marketing Start 2023-12-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219612
Hyphenated Format 65219-612

Supplemental Identifiers

RxCUI
797544 2640851 2640859 2640864 2640869
UPC
0365219618027 0365219610021

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-aacf (source: ndc)
Generic Name adalimumab (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 CARTON in 1 CARTON (65219-612-69) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)
  • 3 CARTON in 1 CARTON (65219-612-89) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)
  • 1 KIT in 1 CARTON (65219-612-99) * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)
source: ndc

Packages (3)

65219-612-69 2 CARTON in 1 CARTON (65219-612-69) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95) 65219-612-89 3 CARTON in 1 CARTON (65219-612-89) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95) 65219-612-99 1 KIT in 1 CARTON (65219-612-99) * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Adalimumab-aacf ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ed59e023-eb91-482f-a1fe-19a31c0906c2", "openfda": {"upc": ["0365219618027", "0365219610021"], "rxcui": ["797544", "2640851", "2640859", "2640864", "2640869"], "spl_set_id": ["2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915"], "manufacturer_name": ["Fresenius Kabi USA, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 CARTON (65219-612-69)  / 1 KIT in 1 CARTON *  .8 mL in 1 SYRINGE, GLASS (65219-610-02)  *  1 SWAB in 1 POUCH (65219-332-95)", "package_ndc": "65219-612-69", "marketing_start_date": "20240930"}, {"sample": false, "description": "3 CARTON in 1 CARTON (65219-612-89)  / 1 KIT in 1 CARTON *  .8 mL in 1 SYRINGE, GLASS (65219-610-02)  *  1 SWAB in 1 POUCH (65219-332-95)", "package_ndc": "65219-612-89", "marketing_start_date": "20240930"}, {"sample": false, "description": "1 KIT in 1 CARTON (65219-612-99)  *  .8 mL in 1 SYRINGE, GLASS (65219-610-02)  *  1 SWAB in 1 POUCH (65219-332-95)", "package_ndc": "65219-612-99", "marketing_start_date": "20231206"}], "brand_name": "Adalimumab-aacf", "product_id": "65219-612_ed59e023-eb91-482f-a1fe-19a31c0906c2", "dosage_form": "KIT", "product_ndc": "65219-612", "generic_name": "adalimumab", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adalimumab-aacf", "application_number": "BLA761255", "marketing_category": "BLA", "marketing_start_date": "20231206", "listing_expiration_date": "20271231"}