ELUCIREM

Product NDC: 67684-4250
11-digit product format: 676844250
Labeler code: 67684
Product ID: 67684-4250_e15d694f-7809-4715-a8c8-a432c05760cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gadopiclenol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Guerbet LLC
Application: NDA216986
Marketing category: NDA
Marketing start: 2022-09-21
Substance: GADOPICLENOL
Active strength: 485.1 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ELUCIREM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GADOPICLENOL	485.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S276568KOY	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
ca582f31-1042-487f-82e4-533f1b541902	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
7de6d8a6-e2ca-4b92-a0a2-a9fccba6d53a	Product name	1	20230905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67684-4250-1	ML - Milliliter	67684-4250	7b4af562-77f5-439b-9c46-aa16ee2aae81	1	2023-01-09
67684-4250-2	ML - Milliliter	67684-4250	9c34db0a-9896-4653-9625-353d405f3052	1	2023-01-09
67684-4250-3	ML - Milliliter	67684-4250	f01698f8-c9fb-4383-aefe-da2a0a9b9fb2	1	2023-01-09
67684-4250-4	ML - Milliliter	67684-4250	0a5c9383-7701-4064-abf8-f0aba991fd7a	1	2023-01-09
67684-4250-5	ML - Milliliter	67684-4250	a4ef1f91-2794-4dcc-a275-309740d4bc93	1	2023-01-09
67684-4250-6	ML - Milliliter	67684-4250	13c10981-e502-4451-bd0a-1c3f4651c3bd	1	2023-01-09
67684-4250-7	ML - Milliliter	67684-4250	e35ccd83-1002-44dc-99ac-de1716274faf	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67684-4250	ELUCIREM (GADOPICLENOL) INJECTION [GUERBET LLC]	7	Current NDC, Legacy NDC	20250311_ca582f31-1042-487f-82e4-533f1b541902.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
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
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): 67684-4250

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S276568KOY	GADOPICLENOL	933983-75-6	GADOPICLENOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67684-4250-1	67684425001	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current
67684-4250-2	67684425002	25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current
67684-4250-3	67684425003	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current
67684-4250-4	67684425004	25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current
67684-4250-5	67684425005	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current
67684-4250-6	67684425006	6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current
67684-4250-7	67684425007	12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	2022-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELUCIREM	Guerbet LLC \| Liebel-Flarsheim Company LLC \| Guerbet \| BIPSO GmbH	2026-02-22	HUMAN PRESCRIPTION DRUG LABEL	13