Home NDC 65219-287 Gadobutrol
Product NDC 65219-287
11-digit product format 652190287
Labeler code 65219
Product ID 65219-287_d546f4fe-ebb3-47cf-9222-563d15caa8b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gadobutrol
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA216081
Marketing category ANDA
Marketing start 2023-10-01
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 42 .
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 A216081-001 GADOBUTROL GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 A216081-002 GADOBUTROL GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 A216081-003 GADOBUTROL GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 A216081-004 GADOBUTROL GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 A216081-005 GADOBUTROL GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 A216081-006 GADOBUTROL GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 94 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 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216081-005 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216081-006 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS 2022-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216081-005 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216081-006 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216081-005 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216081-006 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216081-005 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216081-006 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216081-005 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216081-006 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216081-005 GADOBUTROL 6.0472GM/10ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216081-006 GADOBUTROL 9.0708GM/15ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216081-001 GADOBUTROL 18.1416GM/30ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216081-002 GADOBUTROL 39.3068GM/65ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2023-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216081-003 GADOBUTROL 1.20944GM/2ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216081-004 GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-17 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book exclusivity history# 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 65219-287-10 Gadobutrol 30 mL in 1 BOTTLE INJECTION 30 4 65219-287-30 Gadobutrol 10 in 1 CARTON INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-287 GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC] 2 Current NDC, 2 package rows 20250119_c0dd1618-0bb3-4974-846b-e5afc2311ae6.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-287-10 65219028710 30 mL in 1 BOTTLE 30 ml Historical 65219-287-30 65219028730 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10) 10 bottle 2023-10-01 No No Current