FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
72819-149
11-digit product format
728190149
Labeler code
72819
Product ID
72819-149_28899230-4ee7-c689-e063-6294a90a1b6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Archis Pharma LLC
Application
ANDA090664
Marketing category
ANDA
Marketing start
2024-12-07
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
2.5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE2.5 mg/mL

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
72819-149-06Nicardipine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION102
72819-149-07Nicardipine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72819-149-06ML - Milliliter72819-149a3cee9a4-9d06-4742-8dd9-8cf7a1f6074012025-01-14
72819-149-07ML - Milliliter72819-14962f16f2c-f699-4cd8-9358-a59e13a5f70612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72819-149NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [ARCHIS PHARMA LLC]2Current NDC, 2 package rows20241208_d0070638-bea5-413a-8658-4c752c6104f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNd0070638-bea5-413a-8658-4c752c6104f52
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDd0070638-bea5-413a-8658-4c752c6104f52
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYd0070638-bea5-413a-8658-4c752c6104f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72819-149-067281901490610 mL in 1 VIAL10 mlHistorical
72819-149-077281901490710 VIAL in 1 CARTON (72819-149-07) / 10 mL in 1 VIAL (72819-149-06) 10 vial2024-12-07NoNoCurrent