FDA.reportPublic FDA data

DOTAREM

Product NDC
67684-2000
11-digit product format
676842000
Labeler code
67684
Product ID
67684-2000_313093fe-89fb-4ca8-973c-f36175bb47df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadoterate meglumine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Guerbet LLC
Application
NDA204781
Marketing category
NDA
Marketing start
2013-03-20
Substance
GADOTERATE MEGLUMINE
Active strength
376.9 mg/mL
Pharmacologic classes
Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOTAREM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GADOTERATE MEGLUMINE376.9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL0ND3981AG

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b2d15dc-225b-aca9-f9ef-b38666fe1e57Product name420250620
c34d3757-8380-f2a9-d77b-04fccc1c986eProduct name420250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54Product name120140508
51162ac0-9a99-d9a1-b417-523615d04171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67684-2000-42023-12-28C16284748780-1f386c649-9c83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM ® (gadoterate meglumine) Injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013
67684-2000-42023-01-30C16284748780-1f386c649-9c83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOTAREM safely and effectively. See full prescribing information for DOTAREM. DOTAREM ® (gadoterate meglumine) Injection for intravenous use PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67684-2000-0DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-0DOTAREM5 mL in 1 VIALINJECTION525
67684-2000-1DOTAREM10 mL in 1 VIALINJECTION1025
67684-2000-1DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-2DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-2DOTAREM15 mL in 1 VIALINJECTION1525
67684-2000-3DOTAREM20 mL in 1 VIALINJECTION2025
67684-2000-3DOTAREM10 in 1 PACKAGEINJECTION1025
67684-2000-5DOTAREM5 in 1 PACKAGEINJECTION525
67684-2000-5DOTAREM10 mL in 1 SYRINGEINJECTION1025
67684-2000-6DOTAREM15 mL in 1 SYRINGEINJECTION1525
67684-2000-6DOTAREM5 in 1 PACKAGEINJECTION525
67684-2000-7DOTAREM20 mL in 1 SYRINGEINJECTION2025
67684-2000-7DOTAREM5 in 1 PACKAGEINJECTION525
67684-2000-4DOTAREM6 in 1 PACKAGEInjection617
67684-2000-4DOTAREM100 mL in 1 VIALInjection10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67684-2000-0ML - Milliliter67684-200037f15795-d63f-460a-9206-c5c0da62856412019-01-24
67684-2000-1ML - Milliliter67684-20003016fd32-3e7d-4b63-ba2c-b9a9e3d6d79f12013-09-04
67684-2000-2ML - Milliliter67684-2000d47ebf69-7683-4f57-9b86-2abf8caf6d7212013-09-04
67684-2000-3ML - Milliliter67684-2000b3ecd5e5-11e1-43da-876e-5c5f327e2b0912013-09-04
67684-2000-4ML - Milliliter67684-20006b70e2f1-b672-4e34-82fa-30c23d0c3eca12013-09-04
67684-2000-5ML - Milliliter67684-20002664bf82-741c-4f1e-b761-f9d56049b77f12013-10-17
67684-2000-6ML - Milliliter67684-20003c7eb227-6a12-449b-ae4c-9919aa3b918712013-10-17
67684-2000-7ML - Milliliter67684-2000a6a6a298-2b05-46fe-8f1d-a7f06160918e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gadoterate meglumineACTIVE INGREDIENTL0ND3981AGDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]3
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]3
gadoterate meglumineACTIVE INGREDIENTL0ND3981AGDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]2
GADOLINIUM CATION (3+)ACTIVE MOIETYAZV954TZ9NDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RDOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67684-2000DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]25Current NDC, Legacy NDC, 14 package rows20250321_e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc.zip
67684-2000DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]17Current NDC, Legacy NDC, 2 package rows20250321_82b83e61-6af8-4225-aa39-8cbf206f65b0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67684-2000-06768420000010 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL10 vial2017-03-310000-00-00NoNoCurrent
67684-2000-16768420000110 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL10 vial2013-03-200000-00-00NoNoCurrent
67684-2000-26768420000210 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL10 vial2013-03-200000-00-00NoNoCurrent
67684-2000-36768420000310 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL10 vial2013-03-200000-00-00NoNoCurrent
67684-2000-4676842000046 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL6 vial2013-04-260000-00-00NoNoCurrent
67684-2000-5676842000055 SYRINGE in 1 PACKAGE (67684-2000-5) > 10 mL in 1 SYRINGE5 syringe2013-03-200000-00-00NoNoCurrent
67684-2000-6676842000065 SYRINGE in 1 PACKAGE (67684-2000-6) > 15 mL in 1 SYRINGE5 syringe2013-03-200000-00-00NoNoCurrent
67684-2000-7676842000075 SYRINGE in 1 PACKAGE (67684-2000-7) > 20 mL in 1 SYRINGE5 syringe2013-03-200000-00-00NoNoCurrent