FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cleviprex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEVIDIPINE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19O2GP3B7Q
Rxcui1790239, 1790242, 1790245, 1790246, 1790247, 1790248

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
061e31e4-ddb6-adbf-d142-fd7f75af1bf9Product name220200505
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
18124-011-00Cleviprex1 in 1 CARTONEMULSION14
18124-011-00Cleviprex10 in 1 CARTONEMULSION104
18124-011-25Cleviprex1 in 1 CARTONEMULSION14
18124-011-25Cleviprex4 in 1 CARTONEMULSION44
18124-011-50Cleviprex1 in 1 CARTONEMULSION14
18124-011-50Cleviprex10 in 1 CARTONEMULSION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
18124-011CLEVIPREX (CLEVIDIPINE) EMULSION [FRESENIUS KABI AUSTRIA GMBH]4Current NDC, Legacy NDC, 6 package rows20221118_a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790247clevidipine 125 MG in 250 ML InjectionPSNa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790239clevidipine 25 MG in 50 ML InjectionPSNa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790245clevidipine 50 MG in 100 ML InjectionPSNa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790248Cleviprex 125 MG in 250 ML InjectionPSNa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790242Cleviprex 25 MG in 50 ML InjectionPSNa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790246Cleviprex 50 MG in 100 ML InjectionPSNa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790246100 ML clevidipine 0.5 MG/ML Injection [Cleviprex]SBDa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790248250 ML clevidipine 0.5 MG/ML Injection [Cleviprex]SBDa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
179024250 ML clevidipine 0.5 MG/ML Injection [Cleviprex]SBDa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790245100 ML clevidipine 0.5 MG/ML InjectionSCDa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790247250 ML clevidipine 0.5 MG/ML InjectionSCDa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
179023950 ML clevidipine 0.5 MG/ML InjectionSCDa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790247clevidipine 125 MG per 250 ML InjectionSYa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790239clevidipine 25 MG per 50 ML InjectionSYa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790245clevidipine 50 MG per 100 ML InjectionSYa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790248Cleviprex 125 MG per 250 ML InjectionSYa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790242Cleviprex 25 MG per 50 ML InjectionSYa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304
1790246Cleviprex 50 MG per 100 ML InjectionSYa6826aa3-fabb-4ff1-a7a3-cd4c34e3a3304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
18124-011-001812400110010 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE10 carton2008-09-150000-00-00NoNoCurrent
18124-011-25181240011254 CARTON in 1 CARTON (18124-011-25) / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USE4 carton2008-09-150000-00-00NoNoCurrent
18124-011-501812400115010 CARTON in 1 CARTON (18124-011-50) / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE10 carton2008-09-150000-00-00NoNoCurrent