FDA.reportPublic FDA data

Cardene

Product NDC
68151-0089
11-digit product format
681510089
Labeler code
68151
Product ID
68151-0089_f4b1511d-945c-41fa-8fcf-f30e931526b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020005
Marketing category
NDA
Marketing start
1992-02-21
Marketing end
0000-00-00
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 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
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0089-02020-01-31C16284748780-19d75b9d1-27d8-f424-e053-dadaa90a57ceCARDENE SR (nicardipine hydrochloride) SUSTAINED RELEASE CAPSULES ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0089-0Cardene SR1 in 1 PACKAGECAPSULE, EXTENDED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3CARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
NICARDIPINEACTIVE MOIETYCZ5312222SCARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CORNINACTIVE INGREDIENT0N8672707OCARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JCARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0089CARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_613c79eb-b34d-4fea-82d0-61b8c4840182.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858589Cardene SR 30 MG 12HR Extended Release Oral CapsulePSN613c79eb-b34d-4fea-82d0-61b8c48401823
858587niCARdipine HCl 30 MG 12HR Extended Release Oral CapsulePSN613c79eb-b34d-4fea-82d0-61b8c48401823
85858912 HR nicardipine hydrochloride 30 MG Extended Release Oral Capsule [Cardene]SBD613c79eb-b34d-4fea-82d0-61b8c48401823
85858712 HR nicardipine hydrochloride 30 MG Extended Release Oral CapsuleSCD613c79eb-b34d-4fea-82d0-61b8c48401823
85858912 HR Cardene 30 MG Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823
858589Cardene 30 MG 12 HR Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823
858589Cardene SR 30 MG 12 HR Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823
858587nicardipine hydrochloride 30 MG 12 HR Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0089-0681510089001 in 1 PACKAGEHistorical