Ranolazine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranolazine extended-release tablets, 500 mg

NDC 72578-064-14

60 Tablets

Rx only

Viona

container Label 500mg
(click image for full-size original)

Ranolazine extended-release tablets, 1000 mg

NDC 72578-065-14

60 Tablets

Rx only

Viona

container Label 1000mg
(click image for full-size original)
RANOLAZINE ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-064
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 — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM HYDROXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color ORANGE (Light Orange) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 588
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-064-14 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:72578-064-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:72578-064-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:72578-064-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-064-30)
4 NDC:72578-064-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (72578-064-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210188 09/10/2019
RANOLAZINE ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-065
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 — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM HYDROXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
TALC
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Product Characteristics
Color YELLOW (Pale Yellow) Score no score
Shape OVAL Size 22mm
Flavor Imprint Code 589
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-065-14 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:72578-065-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:72578-065-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:72578-065-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-065-30)
4 NDC:72578-065-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (72578-065-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210188 09/10/2019
Labeler — Viona Pharmaceuticals Inc (081468959)
Registrant — Cadila Healthcare Limited (650199482)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 677605858 ANALYSIS (72578-064), ANALYSIS (72578-065), MANUFACTURE (72578-064), MANUFACTURE (72578-065)

Revised: 11/2019 Viona Pharmaceuticals Inc

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