NICARDIPINE HYDROCHLORIDE

Product NDC
69292-620
11-digit product format
692920620
Labeler code
69292
Product ID
69292-620_3833f906-a53d-44ee-a0a2-17e6bee1d676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amici Pharma Inc
Application
ANDA215377
Marketing category
ANDA
Marketing start
2026-01-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NICARDIPINE HYDROCHLORIDE
Listing expiration
2027-12-31

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
69292-620-90NICARDIPINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-620-90EA - Each69292-6205204ac24-6e34-4838-addc-6910580c259e12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSNedda985c-004e-4487-b856-13cf2cdb900f1
858616niCARdipine HCl 30 MG Oral CapsulePSNedda985c-004e-4487-b856-13cf2cdb900f1
858613nicardipine hydrochloride 20 MG Oral CapsuleSCDedda985c-004e-4487-b856-13cf2cdb900f1
858616nicardipine hydrochloride 30 MG Oral CapsuleSCDedda985c-004e-4487-b856-13cf2cdb900f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69292-620-906929206209090 CAPSULE in 1 BOTTLE (69292-620-90) 90 capsule2026-01-15NoNoCurrent