Losartan Potassium (Page 8 of 8)

Package/Label Display Panel – Carton – 25 mg

25 mg Losartan Potassium Tablets Carton
(click image for full-size original)

NDC 68084- 346 -01

Losartan Potassium
Tablets, USP

25 mg

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Tablet Contains:
Losartan potassium, USP……………………………………………..25 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [See USP Controlled Room
Temperature]. Protect from light.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 68382-135, Zydus Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

034601 0234601/1118A

Package/Label Display Panel – Blister – 25 mg

25 mg Losartan Potassium Tablet Blister
(click image for full-size original)

Losartan Potassium Tablet, USP

25 mg

Package/Label Display Panel – Carton – 50 mg

50 mg Losartan Potassium Tablets Carton
(click image for full-size original)

NDC 68084- 347 -01

Losartan Potassium
Tablets, USP

50 mg

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Tablet Contains:
Losartan potassium, USP……………………………………..50 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [See USP Controlled
Room Temperature]. Protect from light.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 68382-136, Zydus Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

034701 0234701/1218

Package/Label Display Panel – Blister – 50 mg

50 mg Losartan Potassium Tablet Blister
(click image for full-size original)

Losartan Potassium Tablet, USP

50 mg

Package/Label Display Panel – Carton – 100 mg

100 mg Losartan Potassium Tablets Carton
(click image for full-size original)

NDC 68084- 348 -01

Losartan Potassium
Tablets, USP

100 mg

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Patient
Information Sheet to each patient.

Each Tablet Contains:
Losartan potassium, USP……………………………………100 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Protect from light.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 68382-137, Zydus Pharmaceuticals USA Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

034801 0234801/0918A

Package/Label Display Panel – Blister – 100 mg

100 mg Losartan Potassium Tablet Blister
(click image for full-size original)

Losartan Potassium Tablet, USP

100 mg

LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-346(NDC:68382-135)
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
SILICON DIOXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 8mm
Flavor Imprint Code Z;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-346-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-346-11)
1 NDC:68084-346-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-346-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/12/2010
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-347(NDC:68382-136)
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
SILICON DIOXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score 2 pieces
Shape CAPSULE (CAPSULE) Size 11mm
Flavor Imprint Code Z16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-347-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-347-11)
1 NDC:68084-347-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-347-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/12/2010
LOSARTAN POTASSIUM losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-348(NDC:68382-137)
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
SILICON DIOXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 12mm
Flavor Imprint Code Z18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-348-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-348-11)
1 NDC:68084-348-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-348-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/13/2010
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-346), repack (68084-347), repack (68084-348)

Revised: 11/2019 American Health Packaging

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