Ranolazine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50
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30
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RANOLAZINE ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-722(NDC:67877-525)
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
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
SODIUM HYDROXIDE
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange Score no score
Shape OVAL (Oval shaped biconvex) Size 17mm
Flavor Imprint Code A47;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-722-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-722-11)
1 NDC:50268-722-11 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX (50268-722-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209953 09/20/2022
RANOLAZINE ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-723(NDC:67877-526)
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
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
SODIUM HYDROXIDE
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 4000
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape OVAL (Oval shaped biconvex) Size 21mm
Flavor Imprint Code A48;1000
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-723-13 30 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-723-11)
1 NDC:50268-723-11 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX (50268-723-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209953 09/20/2022
Labeler — AvPAK (832926666)

Revised: 09/2022 AvPAK

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