Cleviprex

Product NDC: 10122-611
11-digit product format: 101220611
Labeler code: 10122
Product ID: 10122-611_e472cde4-d29e-44b2-b1ca-a6f4fcc01b1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clevipidine
Dosage form: EMULSION
Route: INTRAVENOUS
Labeler: Chiesi USA, Inc.
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#

Ingredient, Strength table
Ingredient	Strength
CLEVIDIPINE	.5 mg/mL

Field, Values table
Field	Values
Unii	19O2GP3B7Q
Rxcui	1790239, 1790242, 1790245, 1790246

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
061e31e4-ddb6-adbf-d142-fd7f75af1bf9	Product name	2	20200505
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10122-611-01	Cleviprex	1 in 1 CARTON	EMULSION	1	26
10122-611-01	Cleviprex	100 mL in 1 VIAL, SINGLE-USE	EMULSION	100	26
10122-611-10	Cleviprex	10 in 1 CARTON	EMULSION	10	26

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10122-611-01	ML - Milliliter	10122-611	33dff807-53be-4e4c-9418-2e07a07e83b9	1	2017-07-07
10122-611-10	ML - Milliliter	10122-611	fcb4d2b7-4eeb-407f-af30-5477efa7936c	1	2017-07-07

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10122-611	CLEVIPREX (CLEVIPIDINE) EMULSION [CHIESI USA, INC.]	23	Current NDC, Legacy NDC, 3 package rows	20220928_f9290625-b723-4eda-bab8-a97bef6041f6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19O2GP3B7Q	CLEVIDIPINE	167221-71-8	CLEVIDIPINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1790239	clevidipine 25 MG in 50 ML Injection	PSN	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790245	clevidipine 50 MG in 100 ML Injection	PSN	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790242	Cleviprex 25 MG in 50 ML Injection	PSN	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790246	Cleviprex 50 MG in 100 ML Injection	PSN	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790246	100 ML clevidipine 0.5 MG/ML Injection [Cleviprex]	SBD	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790242	50 ML clevidipine 0.5 MG/ML Injection [Cleviprex]	SBD	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790245	100 ML clevidipine 0.5 MG/ML Injection	SCD	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790239	50 ML clevidipine 0.5 MG/ML Injection	SCD	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790239	clevidipine 25 MG per 50 ML Injection	SY	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790245	clevidipine 50 MG per 100 ML Injection	SY	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790242	Cleviprex 25 MG per 50 ML Injection	SY	f9290625-b723-4eda-bab8-a97bef6041f6	26
1790246	Cleviprex 50 MG per 100 ML Injection	SY	f9290625-b723-4eda-bab8-a97bef6041f6	26

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10122-611-01	10122061101	1 in 1 CARTON						Historical
10122-611-10	10122061110	10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USE	10 carton	2008-09-15	0000-00-00	No	No	Current