FDA.reportPublic FDA data

Nifedipine

Product NDC
47781-369
11-digit product format
477810369
Labeler code
47781
Product ID
47781-369_65a00cac-e629-2739-a84b-1590138105c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
NDA020198
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-06-11
Marketing end
2020-04-01
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
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
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-369-01EA - Each47781-3692bbe8882-f056-4aa9-ba63-d0faeb5bbf0912013-08-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNb8c156e9-71e7-4815-ac9a-d9f51797817715
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSNb8c156e9-71e7-4815-ac9a-d9f51797817715
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDb8c156e9-71e7-4815-ac9a-d9f51797817715
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCDb8c156e9-71e7-4815-ac9a-d9f51797817715
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYb8c156e9-71e7-4815-ac9a-d9f51797817715
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSYb8c156e9-71e7-4815-ac9a-d9f51797817715