DOTAREM

Product NDC: 67684-2001
11-digit product format: 676842001
Labeler code: 67684
Product ID: 67684-2001_313093fe-89fb-4ca8-973c-f36175bb47df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gadoterate meglumine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Guerbet LLC
Application: NDA204781
Marketing category: NDA
Marketing start: 2013-03-20
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	TE codes	RLD / RS	Approval date
N204781-001	DOTAREM	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-002	DOTAREM	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-003	DOTAREM	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-004	DOTAREM	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-005	DOTAREM	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N204781-001	AP
N204781-002	AP
N204781-003	AP
N204781-004	AP
N204781-005	AP

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 6 · 210 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	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N204781-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204781-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204781-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204781-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-005	AP	1	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204781-001	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-002	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-003	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-004	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-005	NPP	2020-08-25	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204781-001	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-002	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-003	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-004	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-005	NPP	2020-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204781-001	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-002	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-003	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-004	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-005	NPP	2020-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204781-001	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-002	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-003	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-004	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-005	NPP	2020-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204781-001	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-002	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-003	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-004	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-005	NPP	2020-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204781-001	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-002	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-003	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-004	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-005	NPP	2020-08-25	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: DOTAREM
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
e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc	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
67684-2001-0	DOTAREM	5 mL in 1 VIAL	INJECTION	5	25
67684-2001-0	DOTAREM	10 in 1 PACKAGE	INJECTION	10	25
67684-2001-1	DOTAREM	10 mL in 1 VIAL	INJECTION	10	25
67684-2001-1	DOTAREM	10 in 1 PACKAGE	INJECTION	10	25
67684-2001-2	DOTAREM	15 mL in 1 VIAL	INJECTION	15	25
67684-2001-2	DOTAREM	10 in 1 PACKAGE	INJECTION	10	25
67684-2001-3	DOTAREM	10 in 1 PACKAGE	INJECTION	10	25
67684-2001-3	DOTAREM	20 mL in 1 VIAL	INJECTION	20	25
67684-2001-4	DOTAREM	6 in 1 PACKAGE	Injection	6	17
67684-2001-4	DOTAREM	100 mL in 1 VIAL	Injection	100	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67684-2001-0	ML - Milliliter	67684-2001	1f220e99-64e2-4148-955f-dca63ea6b50a	1	2021-01-08
67684-2001-2	ML - Milliliter	67684-2001	e7a7902b-a16c-4df5-8ad0-f4f8027e1e25	1	2020-05-08
67684-2001-3	ML - Milliliter	67684-2001	42c3c966-345e-4ad6-bd46-3e1bcf66ce72	1	2020-05-08
67684-2001-4	ML - Milliliter	67684-2001	cc518bb5-9b08-450b-aae7-bfb2ef445c4f	1	2020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
gadoterate meglumine	ACTIVE INGREDIENT	L0ND3981AG	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	3
GADOLINIUM CATION (3+)	ACTIVE MOIETY	AZV954TZ9N	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	3
gadoterate meglumine	ACTIVE INGREDIENT	L0ND3981AG	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	2
GADOLINIUM CATION (3+)	ACTIVE MOIETY	AZV954TZ9N	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67684-2001	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	25	Current NDC, Legacy NDC, 8 package rows	20250321_e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc.zip
67684-2001	DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]	17	Current NDC, Legacy NDC, 2 package rows	20250321_82b83e61-6af8-4225-aa39-8cbf206f65b0.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOTAREM	GADOTERATE MEGLUMINE	Guerbet LLC	e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204781 application number: NDA204781 ndc (product): 67684-2001
DOTAREM	GADOTERATE MEGLUMINE	Guerbet LLC	82b83e61-6af8-4225-aa39-8cbf206f65b0	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204781 application number: NDA204781 ndc (product): 67684-2001

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
67684-2001-0	67684200100	10 VIAL in 1 PACKAGE (67684-2001-0) / 5 mL in 1 VIAL	10 vial	2019-10-24	0000-00-00	No	No	Current
67684-2001-1	67684200101	10 VIAL in 1 PACKAGE (67684-2001-1) / 10 mL in 1 VIAL	10 vial	2019-10-24	0000-00-00	No	No	Current
67684-2001-2	67684200102	10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL	10 vial	2019-10-24	0000-00-00	No	No	Current
67684-2001-3	67684200103	10 VIAL in 1 PACKAGE (67684-2001-3) / 20 mL in 1 VIAL	10 vial	2019-10-24	0000-00-00	No	No	Current
67684-2001-4	67684200104	6 VIAL in 1 PACKAGE (67684-2001-4) / 100 mL in 1 VIAL	6 vial	2013-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOTAREM	Guerbet LLC \| Recipharm Monts \| Simafex \| PCAS Finland O.y \| Liebel-Flarsheim Company LLC	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	25
DOTAREM	Guerbet LLC \| Recipharm \| Simafex \| PCAS Finland O.y \| Liebel-Flarsheim Company LLC	2025-03-12	HUMAN PRESCRIPTION DRUG LABEL	17