Telmisartan and Hydrochlorothiazide

TELMISARTAN AND HYDROCHLOROTHIAZIDE- telmisartan and hydrochlorothiazide tablet
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1123-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
(click image for full-size original)

NDC 70771-1124-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
(click image for full-size original)

NDC 70771-1125-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg

Rx only

90 tablets

Telmisartan HCTZ Tablet
(click image for full-size original)
TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1123
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 40 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
POVIDONE
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
SORBITOL
TALC
Product Characteristics
Color BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Score no score
Shape OVAL (Oblong Shaped) Size 15mm
Flavor Imprint Code 513
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1123-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1123-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1123-8 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1123-2)
3 NDC:70771-1123-2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1123-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204221 10/12/2017
TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1124
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 80 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
POVIDONE
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
SORBITOL
TALC
Product Characteristics
Color BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF WHITE) Score no score
Shape OVAL (Oblong Shaped) Size 17mm
Flavor Imprint Code 514
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1124-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1124-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1124-8 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1124-2)
3 NDC:70771-1124-2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1124-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204221 10/12/2017
TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1125
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 80 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
MEGLUMINE
POVIDONE
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
SORBITOL
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (Mottled Light brown to Mottled Brown) , YELLOW (YELLOW) Score no score
Shape OVAL (Oblong Shaped) Size 17mm
Flavor Imprint Code 515
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1125-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1125-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1125-8 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1125-2)
3 NDC:70771-1125-2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1125-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204221 10/12/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1123), ANALYSIS (70771-1124), ANALYSIS (70771-1125), MANUFACTURE (70771-1123), MANUFACTURE (70771-1124), MANUFACTURE (70771-1125)

Revised: 09/2020 Cadila Healthcare Limited

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