Ranolazine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27241-125-02
60 Tablets
Ranolazine Extended-Release Tablets
500 mg
PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only
ajanta

500mg
(click image for full-size original)

NDC 27241-126-02
60 Tablets
Ranolazine Extended-Release Tablets
1000 mg
PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only Ajanta

1000mg
(click image for full-size original)

RANOLAZINE ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-125
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
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM HYDROXIDE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
POLYSORBATE 80
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code RZ1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-125-02 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:27241-125-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210054 08/23/2019
RANOLAZINE ranolazine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-126
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, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM HYDROXIDE
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
POLYSORBATE 80
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 21mm
Flavor Imprint Code RZ2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-126-02 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:27241-126-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210054 08/23/2019
Labeler — Ajanta Pharma USA Inc. (557554156)
Registrant — Ajanta Pharma Limited (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Ltd., Dahej 862199968 MANUFACTURE (27241-125), MANUFACTURE (27241-126)

Revised: 11/2021 Ajanta Pharma USA Inc.

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