Losartan Potassium

LOSARTAN POTASSIUM- losartan potassium tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-729-01

Losartan Potassium Tablets USP, 25 mg

Rx Only

100 Tablets

Zydus

losapotatabA
(click image for full-size original)

NDC 65841-730-01

Losartan Potassium Tablets USP, 50 mg

Rx Only

100 Tablets

Zydus

losapotatabB
(click image for full-size original)

NDC 65841-731-01

Losartan Potassium Tablets USP, 100 mg

Rx Only

100 Tablets

Zydus

losapotatabC
(click image for full-size original)
LOSARTAN POTASSIUM
losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-729
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
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:65841-729-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-729-16 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-729-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-729-10 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-729-24 10000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/04/2010
LOSARTAN POTASSIUM
losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-730
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
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:65841-730-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-730-16 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-730-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-730-10 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-730-24 10000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/04/2010
LOSARTAN POTASSIUM
losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-731
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
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:65841-731-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-731-16 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-731-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-731-10 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-731-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-731-30)
5 NDC:65841-731-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-731-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/04/2010
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (65841-729), ANALYSIS (65841-730), ANALYSIS (65841-731), MANUFACTURE (65841-729), MANUFACTURE (65841-730), MANUFACTURE (65841-731)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-729), ANALYSIS (65841-730), ANALYSIS (65841-731), MANUFACTURE (65841-729), MANUFACTURE (65841-730), MANUFACTURE (65841-731)

Revised: 09/2020 Cadila Healthcare Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.