Nifedipine

Product NDC
43353-836
11-digit product format
433530836
Labeler code
43353
Product ID
43353-836_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
60 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
43353-836-09EA - Each43353-836783e98eb-1a99-41f5-8be8-80fc2058660312015-01-05
43353-836-30EA - Each43353-8368ef6df12-cc3b-4a5e-938f-8a6d9df37da312014-05-02
43353-836-60EA - Each43353-8369ea187bf-4c70-4b88-8c2a-01f7d0cd200112014-05-02
43353-836-80EA - Each43353-836cb900798-5bde-4953-b9dd-5f7b595e090312014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-836-09433530836099000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-836-09) 2014-03-010000-00-00NoNoCurrent
43353-836-304335308363030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-836-30) 2013-06-130000-00-00NoNoCurrent
43353-836-604335308366090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-836-60) 2013-05-220000-00-00NoNoCurrent
43353-836-8043353083680180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-836-80) 2013-05-230000-00-00NoNoCurrent