Home NDC 67684-3001 DOTAREM
Product NDC 67684-3001
11-digit product format 676843001
Labeler code 67684
Product ID 67684-3001_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 2019-09-18
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204781-001 DOTAREM GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 N204781-002 DOTAREM GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 N204781-003 DOTAREM GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 N204781-004 DOTAREM GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 N204781-005 DOTAREM GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 6 · 215 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204781-001 DOTAREM 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204781-002 DOTAREM 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204781-003 DOTAREM 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204781-004 DOTAREM 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204781-005 DOTAREM 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-03-31 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 200 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DOTAREM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOTERATE MEGLUMINE 376.9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L0ND3981AG Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67684-3001 DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] 25 Current NDC, Legacy NDC, 6 package rows 20250321_e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc.zip
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 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67684-3001-1 67684300101 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-1) / 10 mL in 1 SYRINGE, PLASTIC 2019-09-18 0000-00-00 No No Current 67684-3001-2 67684300102 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-2) / 15 mL in 1 SYRINGE, PLASTIC 2019-09-18 0000-00-00 No No Current 67684-3001-3 67684300103 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC 2019-09-18 0000-00-00 No No Current