Nifedipine

Product NDC
53808-1118
11-digit product format
538081118
Labeler code
53808
Product ID
53808-1118_f325d61e-4ec1-435c-9b12-a677604ee232
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA202987
Marketing category
ANDA
Marketing start
2017-10-30
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
2020-12-31
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
53808-1118-12024-01-30C16284748780-11030e365-1b07-111a-e063-dadaa90a10e2Nifedipine Extended-Release Tablets, USP 30mg, 60mg and 90mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1118-1Nifedipine30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1118NIFEDIPINE TABLET, EXTENDED RELEASE [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190122_ff090952-9f69-43c3-8e29-6e159c72b1c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNff090952-9f69-43c3-8e29-6e159c72b1c51
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDff090952-9f69-43c3-8e29-6e159c72b1c51
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYff090952-9f69-43c3-8e29-6e159c72b1c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53808-1118-15380811180130 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-1118-1) 2017-10-300000-00-00NoNoCurrent