dotarem

Generic: gadoterate meglumine

Labeler: guerbet llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dotarem
Generic Name gadoterate meglumine
Labeler guerbet llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

gadoterate meglumine 376.9 mg/mL

Manufacturer
Guerbet LLC

Identifiers & Regulatory

Product NDC 67684-2000
Product ID 67684-2000_313093fe-89fb-4ca8-973c-f36175bb47df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204781
Listing Expiration 2026-12-31
Marketing Start 2013-03-20

Pharmacologic Class

Classes
gadolinium-based contrast agent [epc] magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 676842000
Hyphenated Format 67684-2000

Supplemental Identifiers

UPC
0367684200110 0367684300124 0367684300117 0367684300131 0367684200103 0367684200134 0367684200127
UNII
L0ND3981AG

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dotarem (source: ndc)
Generic Name gadoterate meglumine (source: ndc)
Application Number NDA204781 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 376.9 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL
  • 10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL
  • 10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL
  • 10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL
source: ndc

Packages (4)

67684-2000-0 10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL 67684-2000-1 10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL 67684-2000-2 10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL 67684-2000-3 10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL

Ingredients (1)

gadoterate meglumine (376.9 mg/mL)

Linked Drug Pages (2)

DOTAREM ndc-match (0.9) DOTAREM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "313093fe-89fb-4ca8-973c-f36175bb47df", "openfda": {"upc": ["0367684200110", "0367684300124", "0367684300117", "0367684300131", "0367684200103", "0367684200134", "0367684200127"], "unii": ["L0ND3981AG"], "spl_set_id": ["e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc"], "manufacturer_name": ["Guerbet LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2000-0)  / 5 mL in 1 VIAL", "package_ndc": "67684-2000-0", "marketing_start_date": "20170331"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2000-1)  / 10 mL in 1 VIAL", "package_ndc": "67684-2000-1", "marketing_start_date": "20130320"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2000-2)  / 15 mL in 1 VIAL", "package_ndc": "67684-2000-2", "marketing_start_date": "20130320"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (67684-2000-3)  / 20 mL in 1 VIAL", "package_ndc": "67684-2000-3", "marketing_start_date": "20130320"}], "brand_name": "DOTAREM", "product_id": "67684-2000_313093fe-89fb-4ca8-973c-f36175bb47df", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "67684-2000", "generic_name": "gadoterate meglumine", "labeler_name": "Guerbet LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOTAREM", "active_ingredients": [{"name": "GADOTERATE MEGLUMINE", "strength": "376.9 mg/mL"}], "application_number": "NDA204781", "marketing_category": "NDA", "marketing_start_date": "20130320", "listing_expiration_date": "20261231"}