FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
69452-436
11-digit product format
694520436
Labeler code
69452
Product ID
69452-436_261ba7ea-d55b-1ba9-e063-6394a90a4c8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217555
Marketing category
ANDA
Marketing start
2024-11-04
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
20 mg/1
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858613, 858616

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
69452-436-19Nicardipine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-436-19EA - Each69452-436cef8fa90-188a-42a4-a465-210379f2fdf312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-436NICARDIPINE HYDROCHLORIDE CAPSULE [BIONPHARMA INC.]2Current NDC, 1 package rows20241105_7bed5d8c-30c2-4598-acf3-2edba825a56d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN7bed5d8c-30c2-4598-acf3-2edba825a56d2
858616niCARdipine HCl 30 MG Oral CapsulePSN7bed5d8c-30c2-4598-acf3-2edba825a56d2
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD7bed5d8c-30c2-4598-acf3-2edba825a56d2
858616nicardipine hydrochloride 30 MG Oral CapsuleSCD7bed5d8c-30c2-4598-acf3-2edba825a56d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-436-196945204361990 CAPSULE in 1 BOTTLE, PLASTIC (69452-436-19) 90 capsule2024-11-04NoNoCurrent