Home NDC 0407-2943 CLARISCAN
Product NDC 0407-2943
11-digit product format 004072943
Labeler code 0407
Product ID 0407-2943_03f42c78-1d36-46fd-b570-042571e5912e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadoterate meglumine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler GE Healthcare
Application ANDA210016
Marketing category ANDA
Marketing start 2019-11-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A210016-001 CLARISCAN GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 A210016-002 CLARISCAN GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 A210016-003 CLARISCAN GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 A210016-004 CLARISCAN GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 A210016-005 CLARISCAN GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24
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 5 · 195 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 2026-08-18 06:07:40 2026-07 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210016-001 CLARISCAN 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210016-002 CLARISCAN 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210016-003 CLARISCAN 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2019-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210016-004 CLARISCAN 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210016-005 CLARISCAN 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2020-11-24 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 195 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CLARISCAN
Listing expiration 2027-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0407-2943-01 CLARISCAN 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 16 0407-2943-01 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-02 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-02 CLARISCAN 15 mL in 1 VIAL, GLASS INJECTION, SOLUTION 15 16 0407-2943-05 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-05 CLARISCAN 20 mL in 1 VIAL, GLASS INJECTION, SOLUTION 20 16 0407-2943-06 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-06 CLARISCAN 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 16 0407-2943-12 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-12 CLARISCAN 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 16 0407-2943-17 CLARISCAN 15 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 15 16 0407-2943-17 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-22 CLARISCAN 20 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 20 16 0407-2943-22 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 16 0407-2943-70 CLARISCAN 10 in 1 BOX INJECTION, SOLUTION 10 12 0407-2943-70 CLARISCAN 100 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0407-2943 CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE] 13 Current NDC, Legacy NDC, 14 package rows 20241116_6f8c9fac-c995-4bf4-950d-ab89deb291b5.zip 0407-2943 CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE] 9 Current NDC, Legacy NDC, 2 package rows 20241116_c9e273b3-481f-4899-8913-95aaddcc7662.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 0407-2943-01 00407294301 10 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS 2019-11-01 0000-00-00 No No Current 0407-2943-02 00407294302 10 VIAL, GLASS in 1 BOX (0407-2943-02) / 15 mL in 1 VIAL, GLASS 2019-11-01 0000-00-00 No No Current 0407-2943-05 00407294305 10 VIAL, GLASS in 1 BOX (0407-2943-05) / 20 mL in 1 VIAL, GLASS 2019-11-01 0000-00-00 No No Current 0407-2943-06 00407294306 10 VIAL, GLASS in 1 BOX (0407-2943-06) / 5 mL in 1 VIAL, GLASS 2019-11-01 0000-00-00 No No Current 0407-2943-12 00407294312 10 SYRINGE, PLASTIC in 1 BOX (0407-2943-12) / 10 mL in 1 SYRINGE, PLASTIC 2020-11-16 0000-00-00 No No Current 0407-2943-17 00407294317 10 SYRINGE, PLASTIC in 1 BOX (0407-2943-17) / 15 mL in 1 SYRINGE, PLASTIC 2020-11-16 0000-00-00 No No Current 0407-2943-22 00407294322 10 SYRINGE, PLASTIC in 1 BOX (0407-2943-22) / 20 mL in 1 SYRINGE, PLASTIC 2020-11-16 0000-00-00 No No Current 0407-2943-70 00407294370 10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTIC 2020-08-04 0000-00-00 No No Current