Home NDC 70436-123 gadoterate meglumine
Product NDC 70436-123
11-digit product format 704360123
Labeler code 70436
Product ID 70436-123_32f1536f-eb01-305c-e063-6294a90a1855
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadoterate meglumine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA218073
Marketing category ANDA
Marketing start 2024-06-28
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 A218073-001 GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 A218073-002 GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 A218073-003 GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 A218073-004 GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 A218073-005 GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17
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 2 · 75 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 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218073-001 GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218073-002 GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218073-003 GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218073-004 GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218073-005 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-17 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 observed states.
Additional Listing Data#
Finished product Yes
Brand name base gadoterate meglumine
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70436-123-31 gadoterate meglumine 5 mL in 1 VIAL INJECTION 5 4 70436-123-31 gadoterate meglumine 10 in 1 CARTON INJECTION 10 4 70436-123-33 gadoterate meglumine 10 in 1 CARTON INJECTION 10 4 70436-123-33 gadoterate meglumine 10 mL in 1 VIAL INJECTION 10 4 70436-123-34 gadoterate meglumine 10 in 1 CARTON INJECTION 10 4 70436-123-34 gadoterate meglumine 15 mL in 1 VIAL INJECTION 15 4 70436-123-35 gadoterate meglumine 10 in 1 CARTON INJECTION 10 4 70436-123-35 gadoterate meglumine 20 mL in 1 VIAL INJECTION 20 4 70436-123-40 gadoterate meglumine 100 mL in 1 VIAL INJECTION 100 4 70436-123-56 gadoterate meglumine 6 in 1 CARTON INJECTION 6 4 70436-123-80 gadoterate meglumine 1 in 1 CARTON INJECTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-123 GADOTERATE MEGLUMINE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 4 Current NDC, 8 package rows 20250422_85404ca7-dbe7-4d06-b30c-4368dcd33b0b.zip 70436-123 GADOTERATE MEGLUMINE INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 4 Current NDC, 3 package rows 20250422_b4159c07-b114-4256-b9a9-e6af811704fa.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 Units Marketing start Sample Exclude flag Status 70436-123-31 70436012331 10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL 10 vial 2024-06-28 No No Current 70436-123-33 70436012333 10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL 10 vial 2024-06-28 No No Current 70436-123-34 70436012334 10 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL 10 vial 2024-06-28 No No Current 70436-123-35 70436012335 10 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL 10 vial 2024-06-28 No No Current 70436-123-40 70436012340 100 mL in 1 VIAL 100 ml Historical 70436-123-56 70436012356 6 VIAL in 1 CARTON (70436-123-56) / 100 mL in 1 VIAL (70436-123-40) 6 vial 2024-08-01 No No Current 70436-123-80 70436012380 1 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40) 1 vial 2024-06-28 No No Current