cleviprex

Generic: clevidipine

Labeler: fresenius kabi austria gmbh
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cleviprex
Generic Name clevidipine
Labeler fresenius kabi austria gmbh
Dosage Form EMULSION
Routes
INTRAVENOUS
Active Ingredients

clevidipine .5 mg/mL

Manufacturer
Fresenius Kabi Austria GmbH

Identifiers & Regulatory

Product NDC 18124-011
Product ID 18124-011_0ef540ec-3e55-44d0-b8b9-e70407a54748
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022156
Listing Expiration 2026-12-31
Marketing Start 2008-09-15

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 18124011
Hyphenated Format 18124-011

Supplemental Identifiers

RxCUI
1790239 1790242 1790245 1790246 1790247 1790248
UNII
19O2GP3B7Q
NUI
N0000000069 N0000175421 M0006414

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cleviprex (source: ndc)
Generic Name clevidipine (source: ndc)
Application Number NDA022156 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE
  • 4 CARTON in 1 CARTON (18124-011-25) / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USE
  • 10 CARTON in 1 CARTON (18124-011-50) / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (3)

18124-011-00 10 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE 18124-011-25 4 CARTON in 1 CARTON (18124-011-25) / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USE 18124-011-50 10 CARTON in 1 CARTON (18124-011-50) / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

clevidipine (.5 mg/mL)

Linked Drug Pages (1)

Cleviprex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0ef540ec-3e55-44d0-b8b9-e70407a54748", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["19O2GP3B7Q"], "rxcui": ["1790239", "1790242", "1790245", "1790246", "1790247", "1790248"], "spl_set_id": ["a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Fresenius Kabi Austria GmbH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 CARTON (18124-011-00)  / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE", "package_ndc": "18124-011-00", "marketing_start_date": "20080915"}, {"sample": false, "description": "4 CARTON in 1 CARTON (18124-011-25)  / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USE", "package_ndc": "18124-011-25", "marketing_start_date": "20080915"}, {"sample": false, "description": "10 CARTON in 1 CARTON (18124-011-50)  / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE", "package_ndc": "18124-011-50", "marketing_start_date": "20080915"}], "brand_name": "Cleviprex", "product_id": "18124-011_0ef540ec-3e55-44d0-b8b9-e70407a54748", "dosage_form": "EMULSION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "18124-011", "generic_name": "clevidipine", "labeler_name": "Fresenius Kabi Austria GmbH", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cleviprex", "active_ingredients": [{"name": "CLEVIDIPINE", "strength": ".5 mg/mL"}], "application_number": "NDA022156", "marketing_category": "NDA", "marketing_start_date": "20080915", "listing_expiration_date": "20261231"}