FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
72485-116
11-digit product format
724850116
Labeler code
72485
Product ID
72485-116_a935edd9-4154-42a4-b769-0824200959e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NICARDIPINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA216420
Marketing category
ANDA
Marketing start
2024-04-03
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-116-01Nicardipine Hydrochloride10 mL in 1 VIALINJECTION101
72485-116-10Nicardipine Hydrochloride10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-116-01ML - Milliliter72485-116a54809d8-5c1e-467e-9a8e-7c126dd132be12024-07-12
72485-116-10ML - Milliliter72485-1163b4bdcaf-9866-4c6a-ac9f-6f110d1cc27c12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-116NICARDIPINE HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240413_7226a518-164b-4755-9624-1cc75c939063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN7226a518-164b-4755-9624-1cc75c9390631
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD7226a518-164b-4755-9624-1cc75c9390631
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY7226a518-164b-4755-9624-1cc75c9390631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-116-017248501160110 mL in 1 VIAL10 mlHistorical
72485-116-107248501161010 VIAL in 1 CARTON (72485-116-10) / 10 mL in 1 VIAL (72485-116-01) 10 vial2024-04-03NoNoHistorical