Nifedipine

Product NDC
53808-0898
11-digit product format
538080898
Labeler code
53808
Product ID
53808-0898_2408db70-f2dd-40d6-8480-a420400b828f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077899
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
30 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53808-0898-12020-01-31C16284748780-19d75b9d0-e9b9-f424-e053-dadaa90a57ceNifedipine Extended-Release Tablets, USP For Oral Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0898-1NifedipineExtended Release30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0898NIFEDIPINE EXTENDED RELEASE (NIFEDIPINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_6e740c6e-483b-4e7d-833f-2e8bdd36d625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN6e740c6e-483b-4e7d-833f-2e8bdd36d6251
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD6e740c6e-483b-4e7d-833f-2e8bdd36d6251
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY6e740c6e-483b-4e7d-833f-2e8bdd36d6251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0898-15380808980130 in 1 BLISTER PACKHistorical