Application 216986

Type: NDA
Sponsor: GUERBET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	1.4553GM/3ML (485.1MG/ML)	Yes	Yes
002	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	3.63825GM/7.5ML (485.1MG/ML)	Yes	Yes
003	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	4.851GM/10ML (485.1MG/ML)	Yes	Yes
004	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	7.2765GM/15ML (485.1MG/ML)	Yes	Yes
005	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	14.553GM/30ML (485.1MG/ML)	Yes	Yes
006	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	24.255GM/50ML (485.1MG/ML)	Yes	Yes
007	ELUCIREM	GADOPICLENOL	SOLUTION;INTRAVENOUS	48.51GM/100ML (485.1MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216986-001	ELUCIREM	GADOPICLENOL	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21
N216986-002	ELUCIREM	GADOPICLENOL	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21
N216986-003	ELUCIREM	GADOPICLENOL	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21
N216986-004	ELUCIREM	GADOPICLENOL	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21
N216986-005	ELUCIREM	GADOPICLENOL	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21
N216986-006	ELUCIREM	GADOPICLENOL	24.255GM/50ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21
N216986-007	ELUCIREM	GADOPICLENOL	48.51GM/100ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216986-001	8114863	2028-09-19		Drug substance	2022-11-28
N216986-001	10973934	2039-08-06		Drug substance	2022-11-28
N216986-001	11590246	2040-01-17		Drug product	2023-03-27
N216986-001	12064487	2040-01-17	U-4424		2026-03-05
N216986-002	8114863	2028-09-19		Drug substance	2022-11-28
N216986-002	10973934	2039-08-06		Drug substance	2022-11-28
N216986-002	11590246	2040-01-17		Drug product	2023-03-27
N216986-002	12064487	2040-01-17	U-4424		2026-03-05
N216986-003	8114863	2028-09-19		Drug substance	2022-11-28
N216986-003	10973934	2039-08-06		Drug substance	2022-11-28
N216986-003	11590246	2040-01-17		Drug product	2023-03-27
N216986-003	12064487	2040-01-17	U-4424		2026-03-05
N216986-004	8114863	2028-09-19		Drug substance	2022-11-28
N216986-004	10973934	2039-08-06		Drug substance	2022-11-28
N216986-004	11590246	2040-01-17		Drug product	2023-03-27
N216986-004	12064487	2040-01-17	U-4424		2026-03-05
N216986-005	8114863	2028-09-19		Drug substance	2022-11-28
N216986-005	10973934	2039-08-06		Drug substance	2022-11-28
N216986-005	11590246	2040-01-17		Drug product	2023-03-27
N216986-005	12064487	2040-01-17	U-4424		2026-03-05
N216986-006	8114863	2028-09-19		Drug substance	2022-11-28
N216986-006	10973934	2039-08-06		Drug substance	2022-11-28
N216986-006	11590246	2040-01-17		Drug product	2023-03-27
N216986-006	12064487	2040-01-17	U-4424		2026-03-05
N216986-007	8114863	2028-09-19		Drug substance	2022-11-28
N216986-007	10973934	2039-08-06		Drug substance	2022-11-28
N216986-007	11590246	2040-01-17		Drug product	2023-03-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 14 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216986-001	NCE	2027-09-21
N216986-001	NPP	2029-02-20
N216986-002	NCE	2027-09-21
N216986-002	NPP	2029-02-20
N216986-003	NCE	2027-09-21
N216986-003	NPP	2029-02-20
N216986-004	NCE	2027-09-21
N216986-004	NPP	2029-02-20
N216986-005	NCE	2027-09-21
N216986-005	NPP	2029-02-20
N216986-006	NCE	2027-09-21
N216986-006	NPP	2029-02-20
N216986-007	NCE	2027-09-21
N216986-007	NPP	2029-02-20

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 5 · 182 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216986-001	ELUCIREM	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-002	ELUCIREM	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-003	ELUCIREM	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-004	ELUCIREM	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-005	ELUCIREM	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-006	ELUCIREM	24.255GM/50ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-007	ELUCIREM	48.51GM/100ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-001	ELUCIREM	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-002	ELUCIREM	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-003	ELUCIREM	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-004	ELUCIREM	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-005	ELUCIREM	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-006	ELUCIREM	24.255GM/50ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-007	ELUCIREM	48.51GM/100ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216986-001	ELUCIREM	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-002	ELUCIREM	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-003	ELUCIREM	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-004	ELUCIREM	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-005	ELUCIREM	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-006	ELUCIREM	24.255GM/50ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-007	ELUCIREM	48.51GM/100ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-001	ELUCIREM	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-002	ELUCIREM	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-003	ELUCIREM	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-004	ELUCIREM	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-005	ELUCIREM	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-006	ELUCIREM	24.255GM/50ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-007	ELUCIREM	48.51GM/100ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-001	ELUCIREM	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-002	ELUCIREM	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-003	ELUCIREM	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-004	ELUCIREM	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-005	ELUCIREM	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-006	ELUCIREM	24.255GM/50ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-007	ELUCIREM	48.51GM/100ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-001	ELUCIREM	1.4553GM/3ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-002	ELUCIREM	3.63825GM/7.5ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-003	ELUCIREM	4.851GM/10ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-004	ELUCIREM	7.2765GM/15ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-005	ELUCIREM	14.553GM/30ML (485.1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-21	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 497 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216986-001	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-001	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-001	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-002	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-002	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-002	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-003	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-003	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-003	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-004	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-004	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-004	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-005	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-005	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-005	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-006	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-006	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-006	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-007	8114863	2028-09-19	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-007	10973934	2039-08-06	Drug substance	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-007	11590246	2040-01-17	Drug product	2023-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-001	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-001	10973934	2039-08-06	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-001	11590246	2040-01-17	Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-002	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-002	10973934	2039-08-06	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-002	11590246	2040-01-17	Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-003	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-003	10973934	2039-08-06	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-003	11590246	2040-01-17	Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-004	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-004	10973934	2039-08-06	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-004	11590246	2040-01-17	Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-005	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-005	10973934	2039-08-06	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-005	11590246	2040-01-17	Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-006	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-006	10973934	2039-08-06	Drug substance	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-006	11590246	2040-01-17	Drug product	2023-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-007	8114863	2028-09-19	Drug substance	2022-11-28	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 182 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216986-001	NCE	2027-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-002	NCE	2027-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-003	NCE	2027-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-004	NCE	2027-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-005	NCE	2027-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-006	NCE	2027-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216986-007	NCE	2027-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-001	NCE	2027-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-002	NCE	2027-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-003	NCE	2027-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-004	NCE	2027-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-005	NCE	2027-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-006	NCE	2027-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216986-007	NCE	2027-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216986-001	NCE	2027-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-002	NCE	2027-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-003	NCE	2027-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-004	NCE	2027-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-005	NCE	2027-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-006	NCE	2027-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216986-007	NCE	2027-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-001	NCE	2027-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-002	NCE	2027-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-003	NCE	2027-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-004	NCE	2027-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-005	NCE	2027-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-006	NCE	2027-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216986-007	NCE	2027-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-001	NCE	2027-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-002	NCE	2027-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-003	NCE	2027-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-004	NCE	2027-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-005	NCE	2027-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-006	NCE	2027-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216986-007	NCE	2027-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-001	NCE	2027-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-002	NCE	2027-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-003	NCE	2027-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-004	NCE	2027-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216986-005	NCE	2027-09-21	`03ed91905a0d…`

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
Vueway	GADOPICLENOL	BRACCO DIAGNOSTICS INC	192725e9-e83e-1a36-33f2-abee55792ab3	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216986 application number: NDA216986 ndc (product): 0270-7030 ndc (product): 0270-7015 ndc (product): 0270-7020 ndc (product): 0270-7035 ndc (product): 0270-7025
ELUCIREM	GADOPICLENOL	Guerbet LLC	ca582f31-1042-487f-82e4-533f1b541902	2026-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216986 application number: NDA216986 ndc (product): 67684-4233 ndc (product): 67684-4231 ndc (product): 67684-4232 ndc (product): 67684-4241 ndc (product): 67684-4230 ndc (product): 67684-4250 ndc (product): 67684-4242 ndc (product): 67684-4240

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-7015	Vueway	Gadopiclenol	BRACCO DIAGNOSTICS INC	NDA	Current
0270-7015	Vueway	Gadopiclenol	BRACCO DIAGNOSTICS INC	NDA	Current
0270-7020	Vueway	Gadopiclenol	BRACCO DIAGNOSTICS INC	NDA	Current
0270-7025	Vueway	Gadopiclenol	BRACCO DIAGNOSTICS INC	NDA	Current
0270-7030	Vueway	Gadopiclenol	BRACCO DIAGNOSTICS INC	NDA	Current
0270-7035	Vueway	Gadopiclenol	BRACCO DIAGNOSTICS INC	NDA	Current
67684-4230	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4230	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4230	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4231	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4231	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4231	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4232	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4232	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4232	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4233	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4240	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4241	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4242	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current
67684-4250	ELUCIREM	gadopiclenol	Guerbet LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85133	SUPPL	2026-02-24
85112	SUPPL	2026-02-24
85147	SUPPL	2026-02-20
81486	SUPPL	2025-03-07
81466	SUPPL	2025-03-06
79414	SUPPL	2024-08-16
79198	SUPPL	2024-07-24
79184	SUPPL	2024-07-24
77351	SUPPL	2024-01-29
77330	SUPPL	2024-01-29
72429	ORIG	2022-10-20
72139	ORIG	2022-09-22
72127	ORIG	2022-09-21
72126	ORIG	2022-09-21