Nifedipine

Product NDC
68645-604
11-digit product format
686450604
Labeler code
68645
Product ID
68645-604_e65df03f-228d-4a7c-e053-2a95a90a37ac
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
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-604NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]25Legacy NDC20241016_e65e1547-08ef-6682-e053-2a95a90a51b7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68645-604-546864506045430 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68645-604-54) 2022-08-160000-00-00NoNoCurrent