Ranolazine

Product NDC
71205-867
11-digit product format
712050867
Labeler code
71205
Product ID
71205-867_278d3fa3-3304-43dc-8a2a-a463c8ae9e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211829
Marketing category
ANDA
Marketing start
2021-08-24
Substance
RANOLAZINE
Active strength
500 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
A6IEZ5M406RANOLAZINE95635-55-5RANOLAZINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-867-0071205086700100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-00) 2021-12-17NoNoHistorical
71205-867-307120508673030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-30) 2021-12-17NoNoHistorical
71205-867-5571205086755500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-55) 2021-12-17NoNoHistorical
71205-867-607120508676060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-60) 2021-12-17NoNoHistorical
71205-867-7271205086772120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-72) 2021-12-17NoNoHistorical
71205-867-7871205086778180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-78) 2021-12-17NoNoHistorical
71205-867-907120508679090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-90) 2021-12-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RanolazineProficient Rx LP2022-03-01HUMAN PRESCRIPTION DRUG LABEL2