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

R_x only

90 tablets

NDC 70771-1124-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg

R_x only

90 tablets

NDC 70771-1125-9 in bottle of 90 tablets

Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg

R_x only

90 tablets

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