67684-2000 NDC - DOTAREM ()

Drug Information

Product NDC: 67684-2000

Proprietary Name: DOTAREM

Non Proprietary Name:

Active Ingredient(s):


Administration Route(s):

Dosage Form(s):

Pharmacy Class(es):
  • Gadolinium-based Contrast Agent [EPC];
  • Magnetic Resonance Contrast Activity [MoA]

Labeler Information

Labeler Name: Guerbet LLC
Product Type:
FDA Application Number:
Marketing Category:
Start Marketing Date:4/26/2013

Package Information

No. Package Code Package Description Billing Unit
167684-2000-010 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIALML
267684-2000-110 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIALML
367684-2000-210 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIALML
467684-2000-310 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIALML
567684-2000-46 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIALML
667684-2000-55 SYRINGE in 1 PACKAGE (67684-2000-5) / 10 mL in 1 SYRINGEML
767684-2000-65 SYRINGE in 1 PACKAGE (67684-2000-6) / 15 mL in 1 SYRINGEML
867684-2000-75 SYRINGE in 1 PACKAGE (67684-2000-7) / 20 mL in 1 SYRINGEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC67684-2000The 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 NAMEDOTAREMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE4/26/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMEGuerbet LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC67684-2000The 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 NAMEDOTAREMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/20/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMEGuerbet LLCName of Company corresponding to the labeler code segment of the Product NDC.

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