nifedipine

Product NDC
53808-0496
11-digit product format
538080496
Labeler code
53808
Product ID
53808-0496_cb95c93f-4e5e-4ae7-a755-b24d2d6e6474
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIFEDIPINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA019684
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
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
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0496-12019-10-21C16284748780-1956f9ecf-bd15-621f-e053-dbdaa90a74adNIFEDIPINE EXTENDED-RELEASE TABLETS 30 mg, 60 mg and 90 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0496-1nifedipine30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0496NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100811_ebcf7ace-2b17-41da-93de-7f9bc1b9d10f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNebcf7ace-2b17-41da-93de-7f9bc1b9d10f1
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNebcf7ace-2b17-41da-93de-7f9bc1b9d10f1
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDebcf7ace-2b17-41da-93de-7f9bc1b9d10f1
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDebcf7ace-2b17-41da-93de-7f9bc1b9d10f1
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYebcf7ace-2b17-41da-93de-7f9bc1b9d10f1
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYebcf7ace-2b17-41da-93de-7f9bc1b9d10f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0496-15380804960130 in 1 BLISTER PACKHistorical