Ranolazine (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63304-017-60

Ranolazine Extended-Release Tablets

500 mg

Swallow ranolazine extended-release tablets whole; do not crush, break, or chew.

Rx only

60 Tablets

SUN PHARMA

spl-ranolazine-500mg-label
(click image for full-size original)

Package/Label Display Panel

NDC 63304-018-60

Ranolazine Extended-Release Tablets

1000 mg

Swallow ranolazine extended-release tablets whole; do not crush, break, or chew.

Rx only

60 Tablets

SUN PHARMA

spl-ranolazine-1000mg-label
(click image for full-size original)
RANOLAZINE
ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-017
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
SILICON DIOXIDE
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
MICROCRYSTALLINE CELLULOSE
PEG-10 COCAMINE
SODIUM HYDROXIDE
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
POLYSORBATE 80
LACTOSE MONOHYDRATE
Product Characteristics
Color ORANGE (Light orange) Score no score
Shape OVAL (oblong-shaped) Size 17mm
Flavor Imprint Code RL49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-017-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:63304-017-28 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:63304-017-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211707 05/28/2019
RANOLAZINE
ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-018
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
SILICON DIOXIDE
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
MICROCRYSTALLINE CELLULOSE
PEG-10 COCAMINE
SODIUM HYDROXIDE
TITANIUM DIOXIDE
TRIACETIN
LACTOSE MONOHYDRATE
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
POLYSORBATE 80
Product Characteristics
Color YELLOW (Pale yellow) Score no score
Shape OVAL (oblong-shaped) Size 21mm
Flavor Imprint Code RL50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-018-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:63304-018-28 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:63304-018-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211707 05/28/2019
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Registrant — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650456002 MANUFACTURE (63304-017), MANUFACTURE (63304-018)

Revised: 08/2020 Sun Pharmaceutical Industries, Inc.

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