Home NDC 65293-005 Cleviprex
Product NDC 65293-005
11-digit product format 652930005
Labeler code 65293
Product ID 65293-005_c8c2dc00-90a3-11e4-b4a9-0800200c9a66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clevidipine
Dosage form EMULSION
Route INTRAVENOUS
Labeler The Medicines Company
Application NDA022156
Marketing category NDA
Marketing start 2008-09-15
Marketing end 0000-00-00
Substance CLEVIDIPINE
Active strength 1 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022156-001 CLEVIPREX CLEVIDIPINE 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 N022156-002 CLEVIPREX CLEVIDIPINE 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 N022156-003 CLEVIPREX CLEVIDIPINE 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022156-001 10010537 2031-10-10 Drug product 2018-07-12 N022156-001 11103490 2031-10-10 Drug product 2021-09-01 N022156-001 8658676 2031-10-10 Drug product 2014-03-06 N022156-002 10010537 2031-10-10 Drug product 2018-07-12 N022156-002 11103490 2031-10-10 Drug product 2021-09-01 N022156-002 8658676 2031-10-10 Drug product 2014-03-06 N022156-003 10010537 2031-10-10 Drug product 2018-07-12 N022156-003 11103490 2031-10-10 Drug product 2021-09-01 N022156-003 8658676 2031-10-10 Drug product 2014-03-06
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 · 126 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 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022156-002 CLEVIPREX 50MG/100ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022156-003 CLEVIPREX 125MG/250ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD 2013-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022156-001 CLEVIPREX 25MG/50ML (0.5MG/ML) EMULSION / INTRAVENOUS RLD, RS 2008-08-01 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 10 · 381 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 N022156-001 10010537 2031-10-10 Drug product 2018-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-001 11103490 2031-10-10 Drug product 2021-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-001 8658676 2031-10-10 Drug product 2014-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-002 10010537 2031-10-10 Drug product 2018-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-002 11103490 2031-10-10 Drug product 2021-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-002 8658676 2031-10-10 Drug product 2014-03-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-003 10010537 2031-10-10 Drug product 2018-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-003 11103490 2031-10-10 Drug product 2021-09-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022156-003 8658676 2031-10-10 Drug product 2014-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022156-001 10010537 2031-10-10 Drug product 2018-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-001 11103490 2031-10-10 Drug product 2021-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-001 8658676 2031-10-10 Drug product 2014-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-002 10010537 2031-10-10 Drug product 2018-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-002 11103490 2031-10-10 Drug product 2021-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-002 8658676 2031-10-10 Drug product 2014-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-003 10010537 2031-10-10 Drug product 2018-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-003 11103490 2031-10-10 Drug product 2021-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022156-003 8658676 2031-10-10 Drug product 2014-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-001 10010537 2031-10-10 Drug product 2018-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-001 11103490 2031-10-10 Drug product 2021-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-001 8658676 2031-10-10 Drug product 2014-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-002 10010537 2031-10-10 Drug product 2018-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-002 11103490 2031-10-10 Drug product 2021-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-002 8658676 2031-10-10 Drug product 2014-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-003 10010537 2031-10-10 Drug product 2018-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-003 11103490 2031-10-10 Drug product 2021-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022156-003 8658676 2031-10-10 Drug product 2014-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022156-001 10010537 2031-10-10 Drug product 2018-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-001 11103490 2031-10-10 Drug product 2021-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-001 8658676 2031-10-10 Drug product 2014-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-002 10010537 2031-10-10 Drug product 2018-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-002 11103490 2031-10-10 Drug product 2021-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-002 8658676 2031-10-10 Drug product 2014-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-003 10010537 2031-10-10 Drug product 2018-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-003 11103490 2031-10-10 Drug product 2021-09-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022156-003 8658676 2031-10-10 Drug product 2014-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-001 10010537 2031-10-10 Drug product 2018-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-001 11103490 2031-10-10 Drug product 2021-09-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-001 8658676 2031-10-10 Drug product 2014-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022156-002 10010537 2031-10-10 Drug product 2018-07-12 fd3edfee7708…
DailyMed Socrata Ingredients# 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.