Nifedipine

Product NDC
0378-0360
11-digit product format
003780360
Labeler code
0378
Product ID
0378-0360_d5517e8c-6f72-4ee3-967c-e60b00266b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201071
Marketing category
ANDA
Marketing start
2010-12-20
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
0378-0360-01EA - Each0378-0360a643824c-d050-4071-b3b6-12494fc7352c12012-07-24
0378-0360-10EA - Each0378-0360a55cc1e3-0a2c-41ed-8304-88225952f0ef12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0360-0100378036001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0360-01) 2010-12-200000-00-00NoNoCurrent
0378-0360-10003780360101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0360-10) 2010-12-200000-00-00NoNoCurrent