ranolazine

Product NDC
69844-025
11-digit product format
698440025
Labeler code
69844
Product ID
69844-025_ef140e7b-b519-b66d-e053-2a95a90a2305
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
extended-release
Dosage form
TABLET
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA212889
Marketing category
ANDA
Marketing start
2021-01-28
Marketing end
0000-00-00
Substance
RANOLAZINE
Active strength
1000 mg/1
Pharmacologic classes
Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69844-025-016984400250130 TABLET in 1 BOTTLE (69844-025-01) 30 tablet2021-01-280000-00-00NoNoCurrent
69844-025-026984400250260 TABLET in 1 BOTTLE (69844-025-02) 60 tablet2021-01-280000-00-00NoNoCurrent
69844-025-0369844002503500 TABLET in 1 BOTTLE (69844-025-03) 500 tablet2021-01-280000-00-00NoNoCurrent