Home NDC 18124-011 Cleviprex
Product NDC 18124-011
11-digit product format 181240011
Labeler code 18124
Product ID 18124-011_0ef540ec-3e55-44d0-b8b9-e70407a54748
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clevidipine
Dosage form EMULSION
Route INTRAVENOUS
Labeler Fresenius Kabi Austria GmbH
Application NDA022156
Marketing category NDA
Marketing start 2008-09-15
Substance CLEVIDIPINE
Active strength .5 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 · 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…
Additional Listing Data#
Finished product Yes
Brand name base Cleviprex
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLEVIDIPINE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19O2GP3B7Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790239 Internal RxNorm lookup 1790242 Internal RxNorm lookup 1790245 Internal RxNorm lookup 1790246 Internal RxNorm lookup 1790247 Internal RxNorm lookup 1790248 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 18124-011 CLEVIPREX (CLEVIDIPINE) EMULSION [FRESENIUS KABI AUSTRIA GMBH] 4 Current NDC, Legacy NDC, 6 package rows 20221118_a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 18124-011-00 18124001100 10 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE 10 carton 2008-09-15 0000-00-00 No No Current 18124-011-25 18124001125 4 CARTON in 1 CARTON (18124-011-25) / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USE 4 carton 2008-09-15 0000-00-00 No No Current 18124-011-50 18124001150 10 CARTON in 1 CARTON (18124-011-50) / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE 10 carton 2008-09-15 0000-00-00 No No Current