Nifedipine

Product NDC
43353-750
11-digit product format
433530750
Labeler code
43353
Product ID
43353-750_8433506b-6fac-49c5-bdc6-2fa16d47854b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA201071
Marketing category
ANDA
Marketing start
2012-07-23
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
90 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-750-16EA - Each43353-750a52ae04e-dc0e-4a33-b6fa-5a79db005f0312020-01-03
43353-750-60EA - Each43353-7503a956fcb-64c9-4c8c-b100-cd1488ba8e3412014-05-02
43353-750-81EA - Each43353-7502b3539ea-ed62-4459-9507-c39ed0c8252212014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-750-16433530750166000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-750-16) 2017-05-080000-00-00NoNoCurrent
43353-750-604335307506090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-750-60) 2012-07-250000-00-00NoNoCurrent
43353-750-8143353075081800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-750-81) 2012-07-270000-00-00NoNoCurrent