Home NDC 70436-217 gadobutrol
Product NDC 70436-217
11-digit product format 704360217
Labeler code 70436
Product ID 70436-217_3304ec39-b300-eb0a-e063-6394a90a1cd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadobutrol
Dosage form INJECTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA217480
Marketing category ANDA
Marketing start 2025-04-16
Substance GADOBUTROL
Active strength 604.72 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 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217480-001 GADOBUTROL GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 A217480-002 GADOBUTROL GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 A217480-003 GADOBUTROL GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 A217480-004 GADOBUTROL GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 A217480-005 GADOBUTROL GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 A217480-006 GADOBUTROL GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 · 62 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 2026-02-19 14:30 UTC 2026-02 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217480-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217480-004 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217480-005 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217480-006 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217480-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217480-004 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217480-005 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217480-006 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217480-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217480-004 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217480-005 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217480-006 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2025-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217480-001 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217480-002 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-03-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Additional Listing Data#
Finished product Yes
Brand name base gadobutrol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOBUTROL 604.72 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1BJ477IO2L 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 70436-217-38 gadobutrol 65 mL in 1 VIAL, MULTI-DOSE INJECTION 65 1 70436-217-50 gadobutrol 1 in 1 CARTON INJECTION 1 1 70436-217-78 gadobutrol 65 mL in 1 VIAL, MULTI-DOSE INJECTION 65 1 70436-217-80 gadobutrol 1 in 1 CARTON INJECTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-217 GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20250419_52fbda34-9974-4f9f-9749-6b17d0495b62.zip 70436-217 GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20250419_4af6ee2b-d039-497f-a8f0-bdf948e5f54e.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join gadobutrol GADOBUTROL Slate Run Pharmaceuticals, LLC 52fbda34-9974-4f9f-9749-6b17d0495b62 2025-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217480 application number: ANDA217480 ndc (product): 70436-217 gadobutrol GADOBUTROL Slate Run Pharmaceuticals, LLC 832e0ae1-4fe1-4dff-9978-c9200bcebb55 2025-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217480 application number: ANDA217480 gadobutrol GADOBUTROL Slate Run Pharmaceuticals, LLC 4af6ee2b-d039-497f-a8f0-bdf948e5f54e 2025-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217480 application number: ANDA217480 ndc (product): 70436-217
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70436-217-38 70436021738 65 mL in 1 VIAL, MULTI-DOSE 65 ml Historical 70436-217-50 70436021750 1 VIAL, MULTI-DOSE in 1 CARTON (70436-217-50) / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-78) 2025-04-16 No No Current 70436-217-78 70436021778 65 mL in 1 VIAL, MULTI-DOSE 65 ml Historical 70436-217-80 70436021780 1 VIAL, MULTI-DOSE in 1 CARTON (70436-217-80) / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-38) 2025-04-16 No No Current