FDA.reportPublic FDA data

Nicardipine Hydrochloride in Sodium Chloride

Product NDC
44567-851
11-digit product format
445670851
Labeler code
44567
Product ID
44567-851_9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA203978
Marketing category
ANDA
Marketing start
2025-07-10
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
.2 mg/mL
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 in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858599, 858603

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
44567-851-01Nicardipine Hydrochloride in Sodium Chloride200 mL in 1 BAGINJECTION, SOLUTION2001
44567-851-12Nicardipine Hydrochloride in Sodium Chloride12 in 1 CARTONINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-851-01ML - Milliliter44567-85162f03ce1-723f-41c9-a287-af7b39541fd512025-10-14
44567-851-12ML - Milliliter44567-85137eb509b-2b08-4755-93c3-34e5f873eac812025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858599niCARdipine HCl 20 MG in 200 ML InjectionPSN9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d1
858603niCARdipine HCl 40 MG in 200 ML InjectionPSN9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d1
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCD9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d1
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCD9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d1
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSY9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d1
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSY9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44567-851-0144567085101200 mL in 1 BAG200 mlHistorical
44567-851-124456708511212 BAG in 1 CARTON (44567-851-12) / 200 mL in 1 BAG (44567-851-01) 12 bag2025-07-10NoNoCurrent