69945-120 NDC - THALLOUS CHLORIDE TL 201 (THALLOUS CHLORIDE, TL 201)

Drug Information

Product NDC: 69945-120

Proprietary Name: THALLOUS CHLORIDE Tl 201

Non Proprietary Name: thallous chloride, Tl 201

Active Ingredient(s):
  • 1 mCi/mL THALLOUS CHLORIDE TL-201


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Radioactive Diagnostic Agent [EPC];
  • Radiopharmaceutical Activity [MoA]

Labeler Information

Labeler Name: Curium US LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA018150
Marketing Category: NDA
Start Marketing Date:11/4/2015

Package Information

No. Package Code Package Description Billing Unit
169945-120-281 VIAL in 1 CAN (69945-120-28) / 2.8 mL in 1 VIAL
269945-120-561 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL
369945-120-631 VIAL in 1 CAN (69945-120-63) / 6.3 mL in 1 VIAL
469945-120-991 VIAL in 1 CAN (69945-120-99) / 9.9 mL in 1 VIAL

NDC Record

Field Name Field Value Definition
PRODUCT NDC69945-120The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMETHALLOUS CHLORIDE Tl 201The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEthallous chloride, Tl 201The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/4/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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.
APPLICATION NUMBERNDA018150This 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.
LABELER NAMECurium US LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETHALLOUS CHLORIDE TL-201An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH1 
ACTIVE INGRED UNITmCi/mL 
PHARM CLASSESRadioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] 

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This page was last updated on: 2/1/2023