Ranolazine

Product NDC
43975-290
11-digit product format
439750290
Labeler code
43975
Product ID
43975-290_5d37b8e0-3e6d-4ea3-9d98-4d6faa1c7f02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA210482
Marketing category
ANDA
Marketing start
2020-01-23
Marketing end
2021-11-30
Substance
RANOLAZINE
Active strength
500 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43975-290-06EA - Each43975-290e65d62ce-1b55-423e-afa8-c396db12db4012020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43975-290-064397502900660 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-290-06) 2020-01-232021-11-30NoNoCurrent