Ranolazine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45963-418-06

Ranolazine
Extended-Release
Tablets

500 mg

Swallow tablets whole.Do not crush, break or chew.

Rx only

60 Tablets

label 500 mg 60s
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45963-419-06

Ranolazine
Extended-Release
Tablets

1,000 mg

Swallow tablets whole.Do not crush, break or chew.

Rx only

60 Tablets

label 1000mg 60s
(click image for full-size original)
RANOLAZINE ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-418
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANOLAZINE (RANOLAZINE) RANOLAZINE 500 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
SODIUM HYDROXIDE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color gray Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 418
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-418-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208862 05/28/2019
RANOLAZINE ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-419
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANOLAZINE (RANOLAZINE) RANOLAZINE 1000 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
SODIUM HYDROXIDE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score no score
Shape OVAL Size 22mm
Flavor Imprint Code 419
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-419-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208862 05/28/2019
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 09/2022 Actavis Pharma, Inc.

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