adbry

Generic: tralokinumab-ldrm

Labeler: leo pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name adbry
Generic Name tralokinumab-ldrm
Labeler leo pharma inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

tralokinumab 300 mg/2mL

Manufacturer
LEO Pharma Inc.

Identifiers & Regulatory

Product NDC 50222-350
Product ID 50222-350_8abedac8-f75e-42a0-8591-10fabcf41fb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761180
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Pharmacologic Class

Established (EPC)
interleukin-13 antagonist [epc]
Mechanism of Action
interleukin-13 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50222350
Hyphenated Format 50222-350

Supplemental Identifiers

RxCUI
2589378 2589384 2686061 2686065
UNII
GK1LYB375A
NUI
N0000193985 N0000193986

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 adbry (source: ndc)
Generic Name tralokinumab-ldrm (source: ndc)
Application Number BLA761180 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/2mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (50222-350-01) / 2 mL in 1 SYRINGE, GLASS (50222-350-00)
  • 2 SYRINGE, GLASS in 1 CARTON (50222-350-02) / 2 mL in 1 SYRINGE, GLASS (50222-350-00)
  • 1 SYRINGE, GLASS in 1 CARTON (50222-350-91) / 2 mL in 1 SYRINGE, GLASS (50222-350-90)
source: ndc

Packages (3)

50222-350-01 1 SYRINGE, GLASS in 1 CARTON (50222-350-01) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) 50222-350-02 2 SYRINGE, GLASS in 1 CARTON (50222-350-02) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) 50222-350-91 1 SYRINGE, GLASS in 1 CARTON (50222-350-91) / 2 mL in 1 SYRINGE, GLASS (50222-350-90)

Ingredients (1)

tralokinumab (300 mg/2mL)

Linked Drug Pages (1)

Adbry ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8abedac8-f75e-42a0-8591-10fabcf41fb5", "openfda": {"nui": ["N0000193985", "N0000193986"], "unii": ["GK1LYB375A"], "rxcui": ["2589378", "2589384", "2686061", "2686065"], "spl_set_id": ["d8020b69-3001-44e2-9b5d-5f93d9aaf6e1"], "pharm_class_epc": ["Interleukin-13 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-13 Antagonists [MoA]"], "manufacturer_name": ["LEO Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (50222-350-01)  / 2 mL in 1 SYRINGE, GLASS (50222-350-00)", "package_ndc": "50222-350-01", "marketing_start_date": "20240701"}, {"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (50222-350-02)  / 2 mL in 1 SYRINGE, GLASS (50222-350-00)", "package_ndc": "50222-350-02", "marketing_start_date": "20240701"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (50222-350-91)  / 2 mL in 1 SYRINGE, GLASS (50222-350-90)", "package_ndc": "50222-350-91", "marketing_start_date": "20240701"}], "brand_name": "Adbry", "product_id": "50222-350_8abedac8-f75e-42a0-8591-10fabcf41fb5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-13 Antagonist [EPC]", "Interleukin-13 Antagonists [MoA]"], "product_ndc": "50222-350", "generic_name": "tralokinumab-ldrm", "labeler_name": "LEO Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adbry", "active_ingredients": [{"name": "TRALOKINUMAB", "strength": "300 mg/2mL"}], "application_number": "BLA761180", "marketing_category": "BLA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}