13267-542 NDC - SODIUM FLUORIDE (SODIUM FLUORIDE F 18)

Drug Information

Product NDC: 13267-542

Proprietary Name: Sodium Fluoride

Non Proprietary Name: Sodium Fluoride F 18

Active Ingredient(s):
  • 600 mCi/mL SODIUM FLUORIDE F-18


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION

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

Labeler Information

Labeler Name: THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA204328
Marketing Category: ANDA
Start Marketing Date:11/19/2014

Package Information

No. Package Code Package Description Billing Unit
113267-542-4220 mL in 1 VIAL, GLASS (13267-542-42)

NDC Record

Field Name Field Value Definition
PRODUCT NDC13267-542The 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 NAMESodium FluorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXF 18A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMESodium Fluoride F 18The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTIONThe 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 DATE11/19/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA204328This 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 NAMETHE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM FLUORIDE F-18An 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 STRENGTH600 
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