FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
62559-206
11-digit product format
625590206
Labeler code
62559
Product ID
62559-206_351989dc-ac50-4cf7-a21e-1d70f5a3900c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA074670
Marketing category
ANDA
Marketing start
2021-06-25
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 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
62559-206-90Nicardipine Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-206-90EA - Each62559-2061da7624b-a7e9-412c-9488-62388ee3242d12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-206NICARDIPINE HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20230406_d1e275b8-c71a-4e8b-bca0-cfea048b5343.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSNd1e275b8-c71a-4e8b-bca0-cfea048b53435
858616niCARdipine HCl 30 MG Oral CapsulePSNd1e275b8-c71a-4e8b-bca0-cfea048b53435
858613nicardipine hydrochloride 20 MG Oral CapsuleSCDd1e275b8-c71a-4e8b-bca0-cfea048b53435
858616nicardipine hydrochloride 30 MG Oral CapsuleSCDd1e275b8-c71a-4e8b-bca0-cfea048b53435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-206-906255902069090 CAPSULE in 1 BOTTLE (62559-206-90) 90 capsule2021-06-250000-00-00NoNoCurrent