FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
0378-1020
11-digit product format
003781020
Labeler code
0378
Product ID
0378-1020_f485be32-7e98-4046-a125-b5453c3c2c74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074642
Marketing category
ANDA
Marketing start
1996-07-19
Marketing end
2030-01-31
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1020-05EA - Each0378-1020c86dc3a7-ab5e-4978-9c29-4e74e5a4402712012-07-24
0378-1020-77EA - Each0378-1020185ec88f-bce5-4f58-b155-4933db77a2f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICARDIPINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858613niCARdipine HCl 20 MG Oral CapsulePSN2388174b-8983-4be5-a4b5-f2ec45f3e19c3
858613nicardipine hydrochloride 20 MG Oral CapsuleSCD2388174b-8983-4be5-a4b5-f2ec45f3e19c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1020-0500378102005500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1020-05) 500 capsule1996-07-190000-00-00NoNoCurrent
0378-1020-770037810207790 CAPSULE in 1 BOTTLE, PLASTIC (0378-1020-77) 90 capsule1996-07-190000-00-00NoNoCurrent