11994-090 NDC - TECHNELITE (TECHNETIUM TC99M GENERATOR)

Drug Information

Product NDC: 11994-090

Proprietary Name: TechneLite

Non Proprietary Name: Technetium Tc99m Generator

Active Ingredient(s):
  • 250 mCi/mL TECHNETIUM TC-99M SODIUM PERTECHNETATE


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Labeler Information

Labeler Name: Lantheus Medical Imaging, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA017771
Marketing Category: NDA
Start Marketing Date:11/1/1975

Package Information

No. Package Code Package Description Billing Unit
111994-090-011 VIAL in 1 CARTON (11994-090-01) / 12 mL in 1 VIALEA
211994-090-031 VIAL in 1 CARTON (11994-090-03) / 16 mL in 1 VIAL
311994-090-041 VIAL in 1 CARTON (11994-090-04) / 18 mL in 1 VIAL
411994-090-051 VIAL in 1 CARTON (11994-090-05) / 20 mL in 1 VIAL
511994-090-061 VIAL in 1 CARTON (11994-090-06) / 24 mL in 1 VIAL
611994-090-071 VIAL in 1 CARTON (11994-090-07) / 30 mL in 1 VIAL
711994-090-091 VIAL in 1 CARTON (11994-090-09) / 40 mL in 1 VIAL
811994-090-101 VIAL in 1 CARTON (11994-090-10) / 50 mL in 1 VIAL
911994-090-111 VIAL in 1 CARTON (11994-090-11) / 60 mL in 1 VIAL
1011994-090-121 VIAL in 1 CARTON (11994-090-12) / 72 mL in 1 VIAL
1111994-090-131 VIAL in 1 CARTON (11994-090-13) / 80 mL in 1 VIAL
1211994-090-361 VIAL in 1 CARTON (11994-090-36) / 4 mL in 1 VIALEA
1311994-090-731 VIAL in 1 CARTON (11994-090-73) / 8 mL in 1 VIAL
1411994-090-921 VIAL in 1 CARTON (11994-090-92) / 10 mL in 1 VIAL

NDC Record

Field Name Field Value Definition
PRODUCT NDC11994-090The 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 NAMETechneLiteThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETechnetium Tc99m GeneratorThe 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 DATE11/1/1975This 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 NUMBERNDA017771This 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 NAMELantheus Medical Imaging, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETECHNETIUM TC-99M SODIUM PERTECHNETATEAn 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 STRENGTH250 
ACTIVE INGRED UNITmCi/mL 

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