NDC 50222-346-04 HUMAN PRESCRIPTION DRUG

Drug Status:  Active

Proprietary Name: Adbry

Drug Overview

The NDC Code 50222-346-04 is assigned to “Adbry ” (also known as: “Tralokinumab-ldrm”), a human prescription drug labeled by “LEO Pharma Inc.”. The product's dosage form is injection, solution, and is administered via subcutaneous form.

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Drug Information
NDC Package Code	50222-346-04
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	50222-346
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	50222-0346-04
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Adbry
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Tralokinumab-ldrm
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN PRESCRIPTION DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	LEO Pharma Inc.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	Tralokinumab-ldrm, an interleukin-13 antagonist, is a human IgG4 monoclonal antibody. Tralokinumab-ldrm is produced in mouse myeloma cells by recombinant DNA technology, consists of 1326 amino acids, and has a molecular weight of approximately 147 kilodaltons. ADBRY (tralokinumab-ldrm) injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use supplied as either a single-dose prefilled syringe with needle guard in a siliconized Type-1 clear glass syringe or a single-dose autoinjector with a siliconized Type-1 clear glass syringe inside. None of the components of the prefilled syringe, autoinjector or the needle guard are made with natural rubber latex. Each prefilled syringe delivers 150 mg tralokinumab-ldrm in 1 mL and the inactive ingredients: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5. Each autoinjector delivers 300 mg tralokinumab-ldrm in 2 mL and the inactive ingredients: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5.
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	INJECTION, SOLUTION
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	SUBCUTANEOUS
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	INTERLEUKIN-13 ANTAGONIST [EPC], INTERLEUKIN-13 ANTAGONISTS [MOA]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	TRALOKINUMAB - 150 mg/mL
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	50222-346-04
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	2 CARTON IN 1 CARTON (50222-346-04) / 2 SYRINGE, GLASS IN 1 CARTON (50222-346-22) / 1 ML IN 1 SYRINGE, GLASS (50222-346-01)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20220102
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	50222-346
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	BLA761180
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	BLA
	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Listing Record Certified Through	20261231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20220102
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2025-12-20
	The date that a record was last updated or changed.