NDC 65597-801-01 HUMAN PRESCRIPTION DRUG

Drug Status:  Active

Proprietary Name: Datroway

Drug Overview

The NDC Code 65597-801-01 is assigned to “Datroway ” (also known as: “Datopotamab Deruxtecan”), a human prescription drug labeled by “Daiichi Sankyo Inc.”. The product's dosage form is injection, powder, lyophilized, for solution, and is administered via intravenous form.

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Drug Information
NDC Package Code	65597-801-01
	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	65597-801
	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	65597-0801-01
	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	Datroway
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Datopotamab Deruxtecan
	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	Daiichi Sankyo 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	Datopotamab deruxtecan-dlnk is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. Datopotamab deruxtecan-dlnk is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-Trop-2 IgG1 monoclonal antibody (mAb), covalently linked to 2) a topoisomerase I inhibitor, via 3) a tetrapeptide-based cleavable linker. Deruxtecan is composed of a protease-cleavable maleimide tetrapeptide linker and the topoisomerase inhibitor, DXd, which is an exatecan derivative. The antibody is produced in Chinese hamster ovary cells by recombinant DNA technology, and the topoisomerase inhibitor and linker are produced by chemical synthesis. Approximately 4 molecules of deruxtecan are attached to each antibody molecule. Datopotamab deruxtecan-dlnk has the following structure. DATROWAY (datopotamab deruxtecan-dlnk) for injection is a sterile, white to yellowish white, preservative-free lyophilized powder in single-dose vials. Each vial delivers 100 mg of datopotamab deruxtecan-dlnk, L-histidine (3.88 mg), L-histidine hydrochloride monohydrate (5.25 mg), polysorbate 80 (1.50 mg), and sucrose (450 mg). Following reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration of datopotamab deruxtecan-dlnk is 20 mg/mL with a pH of 6.0. The resulting solution is administered by intravenous infusion following dilution.
	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	DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: 1 adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. (1.1)This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial., 2 adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. (1.2).
	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, POWDER, LYOPHILIZED, FOR 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	INTRAVENOUS
	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	N/S (NOT SPECIFIED)
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	DATOPOTAMAB DERUXTECAN - 100 mg/5mL
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	65597-801-01
	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	1 VIAL, SINGLE-DOSE IN 1 CARTON (65597-801-01) / 5 ML IN 1 VIAL, SINGLE-DOSE
	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	20250117
	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	65597-801
	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	BLA761394
	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	20271231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20250117
	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	2026-01-07
	The date that a record was last updated or changed.