Gadoterate Meglumine

Product NDC: 65219-080
11-digit product format: 652190080
Labeler code: 65219
Product ID: 65219-080_f05922b7-99d4-48c7-972a-7966bbbbc3b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gadoterate meglumine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA215304
Marketing category: ANDA
Marketing start: 2022-06-20
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 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	Approval date
A215304-001	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-002	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-003	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-004	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-005	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-15

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 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A215304-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215304-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215304-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215304-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215304-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215304-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215304-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215304-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215304-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215304-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215304-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215304-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215304-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215304-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215304-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215304-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215304-005	AP	1	`d06236e962d9…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e0655aac-9508-4141-94f5-fcca6af1c41d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5b2d15dc-225b-aca9-f9ef-b38666fe1e57	Product name	4	20250620
c34d3757-8380-f2a9-d77b-04fccc1c986e	Product name	4	20250226
3c495eba-e7eb-cf97-a376-25ae31b0cc54	Product name	1	20140508
51162ac0-9a99-d9a1-b417-523615d04171	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65219-080-01	Gadoterate Meglumine	5 mL in 1 VIAL	INJECTION	5	4
65219-080-01	Gadoterate Meglumine	1 in 1 CARTON	INJECTION	1	4
65219-080-05	Gadoterate Meglumine	10 in 1 BOX	INJECTION	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-080-01	ML - Milliliter	65219-080	8572314e-493a-465c-93f1-d8dd69d1908b	1	2022-10-06
65219-080-05	ML - Milliliter	65219-080	33b825cb-8187-4d8c-80bc-5d876c627904	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-080	GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 3 package rows	20240217_e0655aac-9508-4141-94f5-fcca6af1c41d.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gadoterate Meglumine	GADOTERATE MEGLUMINE	Fresenius Kabi USA, LLC	e0655aac-9508-4141-94f5-fcca6af1c41d	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215304 application number: ANDA215304 ndc (product): 65219-080

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L0ND3981AG	GADOTERATE MEGLUMINE	92943-93-6	GADOTERATE MEGLUMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-080-01	65219008001	5 mL in 1 VIAL	5 ml					Historical
65219-080-05	65219008005	10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL	10 carton	2022-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gadoterate Meglumine	Fresenius Kabi USA, LLC \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	4