Nifedipine

Product NDC
0378-0353
11-digit product format
003780353
Labeler code
0378
Product ID
0378-0353_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
30 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0353-01EA - Each0378-03538b965b09-796a-45f1-bc4a-492e9fcc8f3012012-07-24
0378-0353-10EA - Each0378-0353d3b86f25-0437-4e3e-8cc1-3dec7165e04a12012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN093a8712-c860-4524-86f6-a9edcd35b8821
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD093a8712-c860-4524-86f6-a9edcd35b8821
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY093a8712-c860-4524-86f6-a9edcd35b8821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0353-0100378035301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0353-01) 2010-12-200000-00-00NoNoCurrent
0378-0353-10003780353101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0353-10) 2010-12-200000-00-00NoNoCurrent