Ranolazine

Product NDC
69097-222
11-digit product format
690970222
Labeler code
69097
Product ID
69097-222_7141ddf2-9c11-4d86-a0b3-ec7fd7e035b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA211291
Marketing category
ANDA
Marketing start
2019-05-28
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-222-026909702220230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69097-222-02) 2019-05-280000-00-00NoNoCurrent
69097-222-036909702220360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69097-222-03) 2019-05-280000-00-00NoNoCurrent
69097-222-1269097022212500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69097-222-12) 2019-05-280000-00-00NoNoCurrent