69945-452 NDC - SODIUM IODIDE I 131 ()

Drug Information

  • Product NDC: 69945-452
  • Proprietary Name: SODIUM IODIDE I 131
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: MALLINCKRODT NUCLEAR MEDICINE LLC
Product Type:
FDA Application Number: NDA016517
Marketing Category: NDA
Start Marketing Date:10/27/2015
End Marketing Date:7/1/2018

Package Information

No. Package Code Package Description Billing Unit
169945-452-001 CAPSULE in 1 CAN (69945-452-00) / 100 mL in 1 CAPSULE
269945-452-011 CAPSULE in 1 CAN (69945-452-01) / 1 mL in 1 CAPSULE
369945-452-021 CAPSULE in 1 CAN (69945-452-02) / 2 mL in 1 CAPSULE
469945-452-031 CAPSULE in 1 CAN (69945-452-03) / 3 mL in 1 CAPSULE
569945-452-041 CAPSULE in 1 CAN (69945-452-04) / 4 mL in 1 CAPSULE
669945-452-051 CAPSULE in 1 CAN (69945-452-05) / 5 mL in 1 CAPSULE
769945-452-061 CAPSULE in 1 CAN (69945-452-06) / 6 mL in 1 CAPSULE
869945-452-071 CAPSULE in 1 CAN (69945-452-07) / 7 mL in 1 CAPSULE
969945-452-081 CAPSULE in 1 CAN (69945-452-08) / 8 mL in 1 CAPSULE
1069945-452-091 CAPSULE in 1 CAN (69945-452-09) / 9 mL in 1 CAPSULE
1169945-452-101 CAPSULE in 1 CAN (69945-452-10) / 10 mL in 1 CAPSULE
1269945-452-111 CAPSULE in 1 CAN (69945-452-11) / 11 mL in 1 CAPSULE
1369945-452-121 CAPSULE in 1 CAN (69945-452-12) / 12 mL in 1 CAPSULE
1469945-452-151 CAPSULE in 1 CAN (69945-452-15) / 15 mL in 1 CAPSULE
1569945-452-171 CAPSULE in 1 CAN (69945-452-17) / 17 mL in 1 CAPSULE
1669945-452-201 CAPSULE in 1 CAN (69945-452-20) / 20 mL in 1 CAPSULE
1769945-452-501 CAPSULE in 1 CAN (69945-452-50) / 50 mL in 1 CAPSULE
1869945-452-751 CAPSULE in 1 CAN (69945-452-75) / .75 mL in 1 CAPSULE

NDC Record

Field Name Field Value Definition
PRODUCT NDC69945-452The 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.
PROPRIETARY NAMESODIUM IODIDE I 131The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE10/27/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE7/1/2018This 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.
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 NUMBERNDA016517This 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 NAMEMALLINCKRODT NUCLEAR MEDICINE LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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