Ranexa (Page 6 of 6)

Ranolazine 500 mg tabs

Label ImageLabel Image
RANEXA ranolazine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-5004(NDC:61958-1003)
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
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
CELLULOSE, MICROCRYSTALLINE
SODIUM HYDROXIDE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
WATER
Product Characteristics
Color orange (Light Orange) Score no score
Shape OVAL (oblong-shaped) Size 17mm
Flavor Imprint Code GSI500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-5004-1 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021526 01/27/2006
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-5004)

Revised: 08/2016 Carilion Materials Management

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