Ranolazine (Page 6 of 6)

Principle Display Panel

Ranolazine extended-release tablets, 500 mg

NDC 68462-319-60

60 tablets

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

Principle Display Panel

Ranolazine extended-release tablets, 1000 mg

NDC 68462-320-60

60 tablets

bottle-1000mg-60-tablets
(click image for full-size original)
RANOLAZINE
ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-319
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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
SODIUM LAURYL SULFATE
MICROCRYSTALLINE CELLULOSE
SODIUM HYDROXIDE
TITANIUM DIOXIDE
CARMINIC ACID
POLYETHYLENE GLYCOL 6000
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
TRIACETIN
Product Characteristics
Color PINK Score no score
Shape OVAL (oblong-shaped) Size 15mm
Flavor Imprint Code G;319
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-319-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68462-319-05 500 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 ANDA211082 07/05/2019
RANOLAZINE
ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-320
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
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
SODIUM LAURYL SULFATE
MICROCRYSTALLINE CELLULOSE
SODIUM HYDROXIDE
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE
TRIACETIN
CARMINIC ACID
FD&C RED NO. 40
FD&C YELLOW NO. 6
Product Characteristics
Color BROWN (Reddish Brown) Score no score
Shape OVAL (oblong-shaped) Size 21mm
Flavor Imprint Code G;320
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-320-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68462-320-05 500 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 ANDA211082 07/05/2019
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE (68462-319), MANUFACTURE (68462-320), ANALYSIS (68462-319), ANALYSIS (68462-320)

Revised: 11/2019 Glenmark Pharmaceuticals Inc., USA

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