Losartan Potassium Tablets, 25 Mg (Page 8 of 8)

PACKAGE LABEL

NDC 59746-333 -30

Losartan Potassium
Tablets, USP
25 mg
PHARMACIST: PLEASE DISPENSE WITH
ACCOMPANYING PATIENT INFORMATION LEAFLET.
CADISTA™
30 Tablets
Rx Only

Each coated tablet contains:
Losartan Potassium, USP, 25 mg
Usual Dosage: See accompanying package outsert.
Keep this and all medications out of the reach of children.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Keep container tightly closed.
Protect from Light.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev# 02/17
333
C

25mg
(click image for full-size original)

NDC 59746-334 -30

Losartan Potassium
Tablets, USP

50 mg
PHARMACIST: PLEASE DISPENSE WITH
ACCOMPANYING PATIENT INFORMATION LEAFLET.
CADISTA™
30 Tablets
Rx Only

Each coated tablet contains:
Losartan Potassium, USP, 50 mg
Usual Dosage: See accompanying package outsert.
Keep this and all medications out of the reach of children.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Keep container tightly closed.
Protect from Light.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev# 02/17
334
C

50mg
(click image for full-size original)

NDC 59746-335 -30

Losartan Potassium
Tablets, USP

100 mg
PHARMACIST: PLEASE DISPENSE WITH
ACCOMPANYING PATIENT INFORMATION LEAFLET.
CADISTA™
30 Tablets
Rx Only

Each coated tablet contains:
Losartan Potassium, USP, 100 mg
Usual Dosage: See accompanying package outsert.
Keep this and all medications out of the reach of children.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Keep container tightly closed.
Protect from Light.
Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev# 02/17
335
C

100mg
(click image for full-size original)
LOSARTAN POTASSIUM TABLETS, 25 MG losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-333
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Losartan Potassium (Losartan) Losartan Potassium 25 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
Lactose Monohydrate
Starch, Corn
Magnesium Stearate
Polyvinyl Alcohol, Unspecified
Polyethylene Glycol, Unspecified
Talc
Titanium Dioxide
D&c Yellow No. 10
Aluminum Oxide
Fd&c Blue No. 2
Indigotindisulfonate Sodium
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 8mm
Flavor Imprint Code C;333
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-333-30 30 TABLET in 1 BOTTLE None
2 NDC:59746-333-90 90 TABLET in 1 BOTTLE None
3 NDC:59746-333-01 100 TABLET in 1 BOTTLE None
4 NDC:59746-333-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201170 09/18/2012
LOSARTAN POTASSIUM TABLETS, 50 MG losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-334
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Losartan Potassium (Losartan) Losartan Potassium 50 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
Lactose Monohydrate
Starch, Corn
Magnesium Stearate
Polyvinyl Alcohol, Unspecified
Polyethylene Glycol, Unspecified
Talc
Titanium Dioxide
D&c Yellow No. 10
Aluminum Oxide
Fd&c Blue No. 2
Indigotindisulfonate Sodium
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code C;334
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-334-30 30 TABLET in 1 BOTTLE None
2 NDC:59746-334-90 90 TABLET in 1 BOTTLE None
3 NDC:59746-334-01 100 TABLET in 1 BOTTLE None
4 NDC:59746-334-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201170 09/18/2012
LOSARTAN POTASSIUM TABLETS, 100 MG losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-335
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Losartan Potassium (Losartan) Losartan Potassium 100 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
Lactose Monohydrate
Starch, Corn
Magnesium Stearate
Polyvinyl Alcohol, Unspecified
Polyethylene Glycol, Unspecified
Talc
Titanium Dioxide
D&c Yellow No. 10
Aluminum Oxide
Fd&c Blue No. 2
Indigotindisulfonate Sodium
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 11mm
Flavor Imprint Code C;335
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-335-30 30 TABLET in 1 BOTTLE None
2 NDC:59746-335-90 90 TABLET in 1 BOTTLE None
3 NDC:59746-335-01 100 TABLET in 1 BOTTLE None
4 NDC:59746-335-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201170 09/18/2012
Labeler — Jubilant Cadista Pharmaceuticals Inc. (022490515)
Establishment
Name Address ID/FEI Operations
Jubilant Cadista Pharmaceuticals Inc. 022490515 MANUFACTURE (59746-333), MANUFACTURE (59746-334), MANUFACTURE (59746-335)

Revised: 03/2017 Jubilant Cadista Pharmaceuticals Inc.

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