FDA.reportPublic FDA data

NICARDIPINE HYDROCHLORIDE

Product NDC
42571-394
11-digit product format
425710394
Labeler code
42571
Product ID
42571-394_336c158b-9081-8a80-e063-6294a90a92d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NICARDIPINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Micro Labs Limited
Application
ANDA216420
Marketing category
ANDA
Marketing start
2023-11-01
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-394-88NICARDIPINE HYDROCHLORIDE10 mL in 1 VIALINJECTION102
42571-394-89NICARDIPINE HYDROCHLORIDE10 in 1 CARTONINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-394NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE) INJECTION [MICRO LABS LIMITED]2Current NDC, 2 package rows20250424_8e8611e0-7d8c-4f30-b53a-76c6588b6ef7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSN8e8611e0-7d8c-4f30-b53a-76c6588b6ef72
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCD8e8611e0-7d8c-4f30-b53a-76c6588b6ef72
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSY8e8611e0-7d8c-4f30-b53a-76c6588b6ef72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-394-884257103948810 mL in 1 VIAL10 mlHistorical
42571-394-894257103948910 VIAL in 1 CARTON (42571-394-89) / 10 mL in 1 VIAL (42571-394-88) 10 vial2023-11-01NoNoCurrent