Nifedipine

Product NDC
68645-512
11-digit product format
686450512
Labeler code
68645
Product ID
68645-512_d34af705-9cd4-1e9b-e053-2995a90a90f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA077127
Marketing category
ANDA
Marketing start
2005-11-21
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-512-54EA - Each68645-5121ff60269-0dea-4ce1-8df5-e7351fe3405012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-512NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]7Legacy NDC20241016_09225078-e793-4578-bc34-2758a895720d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68645-512-546864505125430 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68645-512-54) 2005-11-210000-00-00NoNoCurrent