FDA.reportPublic FDA data

NDC 67684-2000-01 - DOTAREM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67684-2000
Requested NDC
67684-2000-01
Package NDCs from labels
67684-2000-1, 67684-2000-0, 67684-2000-2, 67684-2000-3, 67684-2000-5, 67684-2000-6, 67684-2000-7, 67684-2000-4, 67684-2000-01
Manufacturer
Guerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC
Effective date
2025-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DOTAREM - Guerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLCGuerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC2025-03-14HUMAN PRESCRIPTION DRUG LABEL
DOTAREM - Guerbet LLC | Recipharm | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLCGuerbet LLC | Recipharm | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC2025-03-12HUMAN PRESCRIPTION DRUG LABEL

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 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

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
gadoterate meglumineGADOTERATE MEGLUMINESlate Run Pharmaceuticals, LLC85404ca7-dbe7-4d06-b30c-4368dcd33b0b2025-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L0ND3981AG
gadoterate meglumineGADOTERATE MEGLUMINESlate Run Pharmaceuticals, LLCb4159c07-b114-4256-b9a9-e6af811704fa2025-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L0ND3981AG
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
DOTAREMGADOTERATE MEGLUMINEGuerbet LLCe2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA204781
ndc (package): 67684-3001-1
ndc (package): 67684-2000-0
ndc (package): 67684-2000-3
ndc (package): 67684-2000-7
ndc (package): 67684-3001-2
ndc (package): 67684-2000-5
ndc (package): 67684-2001-2
ndc (package): 67684-2000-1
ndc (package): 67684-2001-0
ndc (package): 67684-3001-3
ndc (package): 67684-2000-6
ndc (package): 67684-2001-3
ndc (package): 67684-2000-2
ndc (package): 67684-2001-1
ndc (product): 67684-2001
ndc (product): 67684-3001
ndc (product): 67684-2000
ndc11 (package): 67684200001
spl id: 313093fe-89fb-4ca8-973c-f36175bb47df
spl set id: e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc
unii: L0ND3981AG

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.