Ranexa

Product NDC
61958-1004
11-digit product format
619581004
Labeler code
61958
Product ID
61958-1004_ba1f4469-5e3c-447a-9d28-8e57a2c32a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA021526
Marketing category
NDA
Marketing start
2007-02-12
Marketing end
0000-00-00
Substance
RANOLAZINE
Active strength
1000 mg/1
Pharmacologic classes
Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
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
61958-1004-1EA - Each61958-1004c518e113-0ef0-4f39-850e-2f5254489e9312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-1004-16195810040160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (61958-1004-1) 2007-02-120000-00-00NoNoCurrent
61958-1004-26195810040214 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (61958-1004-2) 2007-02-120000-00-00NoNoCurrent
61958-1004-36195810040314 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (61958-1004-3) 2007-02-120000-00-00NoNoCurrent