FDA.reportPublic FDA data

NICARDIPINE HYDROCHLORIDE

Product NDC
55150-183
11-digit product format
551500183
Labeler code
55150
Product ID
55150-183_4a19b4d6-9b86-4b20-befb-6c50a3898df4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NICARDIPINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA211121
Marketing category
ANDA
Marketing start
2021-04-08
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
25 mg/10mL
Pharmacologic classes
Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [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
NICARDIPINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE25 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858607

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-183-01NICARDIPINE HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION103
55150-183-10NICARDIPINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION103
55150-183-02NICARDIPINE HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102
55150-183-11NICARDIPINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-183-01ML - Milliliter55150-183fc606329-0883-47ed-8fcb-8f9844d9cf9412021-07-15
55150-183-02ML - Milliliter55150-18396491fcd-30e0-4273-9838-eb5157671ac712022-04-06
55150-183-10ML - Milliliter55150-18387a34569-d42d-4028-ad5b-1b469d0fccb112021-07-15
55150-183-11ML - Milliliter55150-1831735e43f-8abc-4d4e-bc50-3fece9de847a12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-183NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20240507_dcd7d173-4d8e-4282-9edf-817711340e43.zip
55150-183NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]2Current NDC, Legacy NDC, 2 package rows20250509_9f5d3050-9cdf-404f-ac0f-72399178959f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNdcd7d173-4d8e-4282-9edf-817711340e433
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDdcd7d173-4d8e-4282-9edf-817711340e433
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYdcd7d173-4d8e-4282-9edf-817711340e433
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN9f5d3050-9cdf-404f-ac0f-72399178959f2
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD9f5d3050-9cdf-404f-ac0f-72399178959f2
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY9f5d3050-9cdf-404f-ac0f-72399178959f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-183-015515001830110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
55150-183-025515001830210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
55150-183-105515001831010 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-01) 2021-04-080000-00-00NoNoCurrent
55150-183-115515001831110 VIAL, SINGLE-DOSE in 1 CARTON (55150-183-11) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-183-02) 2021-04-080000-00-00NoNoCurrent