Home NDC 67684-4240 ELUCIREM
Product NDC 67684-4240
11-digit product format 676844240
Labeler code 67684
Product ID 67684-4240_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 42 .
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 TE codes 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 2032-05-25 Drug substance, Drug product 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 2032-05-25 Drug substance, Drug product 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 2032-05-25 Drug substance, Drug product 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 2032-05-25 Drug substance, Drug product 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 2032-05-25 Drug substance, Drug product 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 2032-05-25 Drug substance, Drug product 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 2032-05-25 Drug substance, Drug product 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.
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 · 189 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 N216986-001 ELUCIREM 1.4553GM/3ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-002 ELUCIREM 3.63825GM/7.5ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-003 ELUCIREM 4.851GM/10ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-004 ELUCIREM 7.2765GM/15ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-005 ELUCIREM 14.553GM/30ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-006 ELUCIREM 24.255GM/50ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-007 ELUCIREM 48.51GM/100ML (485.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-09-21 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 14 · 524 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216986-001 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-001 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-001 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-001 12064487 2040-01-17 U-4424 2026-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-002 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-002 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-002 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-002 12064487 2040-01-17 U-4424 2026-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-003 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-003 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-003 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-003 12064487 2040-01-17 U-4424 2026-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-004 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-004 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-004 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-004 12064487 2040-01-17 U-4424 2026-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-005 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-005 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-005 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-005 12064487 2040-01-17 U-4424 2026-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-006 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-006 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-006 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-006 12064487 2040-01-17 U-4424 2026-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-007 8114863 2032-05-25 Drug substance, Drug product 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-007 10973934 2039-08-06 Drug substance 2022-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216986-007 11590246 2040-01-17 Drug product 2023-03-27 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 196 observed states.
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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67684-4240 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67684-4240-1 67684424001 1 SYRINGE in 1 CARTON (67684-4240-1) / 7.5 mL in 1 SYRINGE 1 syringe 2022-09-21 0000-00-00 No No Current 67684-4240-2 67684424002 10 SYRINGE in 1 CARTON (67684-4240-2) / 7.5 mL in 1 SYRINGE 10 syringe 2022-09-21 0000-00-00 No No Current