Ranolazine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42571-324-60
Ranolazine Extended-Release Tablets
500 mg
Rx only
60 Tablets Micro Labs Limited

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NDC 42571-325-60
Ranolazine Extended-Release Tablets
1,000 mg
Rx only
60 Tablets Micro Labs Limited

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RANOLAZINE ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-324
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
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM HYDROXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
POLYSORBATE 80
Product Characteristics
Color orange (Light orange) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code C49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-324-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:42571-324-64 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:42571-324-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:42571-324-11 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-324-32)
4 NDC:42571-324-32 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (42571-324-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211745 06/01/2020
RANOLAZINE ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-325
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
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM HYDROXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15000 MPA.S)
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE YELLOW
POLYSORBATE 80
SODIUM LAURYL SULFATE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 22mm
Flavor Imprint Code C48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-325-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:42571-325-64 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:42571-325-11 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-325-32)
3 NDC:42571-325-32 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (42571-325-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211745 06/01/2020
Labeler — Micro Labs Limited (862174955)
Establishment
Name Address ID/FEI Operations
Micro Labs Limited 915793658 analysis (42571-324), analysis (42571-325), label (42571-324), label (42571-325), manufacture (42571-324), manufacture (42571-325), pack (42571-324), pack (42571-325)

Revised: 11/2021 Micro Labs Limited

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