Telmisartan and Hydrochlorthiazide (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg Bottle Labels

Telmisartan and Hydrochlorothiazide Tablets, USP

40 mg/12.5 mg

Rx Only

​Important: Moisture sensitive tablets — do not remove from containers until immediately before administration.

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

Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

​​​

indrad-40mg-12-5mg-bottle
(click image for full-size original)

Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

dahej-40mg-12-5mg-bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg Cartons

Telmisartan and Hydrochlorothiazide Tablets, USP

40 mg/12.5 mg

Rx Only

Important: Moisture sensitive tablets — do not remove from blisters until immediately before administration.

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

Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

indrad-40mg-12-5mg-carton
(click image for full-size original)

Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

dahej-40mg-12-5mg-carton
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg/12.5 mg Bottle Labels

Telmisartan and Hydrochlorothiazide Tablets, USP

80 mg/12.5 mg

Rx Only

Important: Moisture sensitive tablets — do not remove from containers until immediately before administration.

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

Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

indrad-80mg-12-5mg-bottle
(click image for full-size original)

Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

dahej-80mg-12-5mg-bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg/12.5 mg Cartons

Telmisartan and Hydrochlorothiazide Tablets, USP

80 mg/12.5 mg

Rx Only

Important: Moisture sensitive tablets — do not remove from blisters until immediately before administration.

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

Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

indrad-80mg-12-5mg-carton
(click image for full-size original)

Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

dahej-80mg-12-5mg-carton
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg/25 mg Bottle Labels

Telmisartan and Hydrochlorothiazide Tablets, USP

80 mg/25 mg

Rx Only

Important: Moisture sensitive tablets — do not remove from containers until immediately before administration.

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

Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

indrad-80mg-25mg-bottle
(click image for full-size original)

Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

dahej-80mg-25mg-bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg/25 mg Cartons

Telmisartan and Hydrochlorothiazide Tablets, USP

80 mg/25 mg

Rx Only

Important: Moisture sensitive tablets — do not remove from blisters until immediately before administration.

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

Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, INDIA.

indrad-80mg-25mg-carton
(click image for full-size original)

Manufactured by: TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

dahej-80mg-25mg-carton
(click image for full-size original)
TELMISARTAN AND HYDROCHLORTHIAZIDE telmisartan and hydrochlorthiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-159
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
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MANNITOL
MEGLUMINE
POVIDONE K30
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (white or off white to yellowish) Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code 1159
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-159-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-159-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-159-74 100 TABLET in 1 CARTON None
4 NDC:13668-159-72 30 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201192 02/25/2014
TELMISARTAN AND HYDROCHLORTHIAZIDE telmisartan and hydrochlorthiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-160
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
FERRIC OXIDE RED
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MANNITOL
MEGLUMINE
POVIDONE K30
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (White or off-white to yellowish) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 1160
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-160-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-160-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-160-74 100 TABLET in 1 CARTON None
4 NDC:13668-160-72 30 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201192 02/25/2014
TELMISARTAN AND HYDROCHLORTHIAZIDE telmisartan and hydrochlorthiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-161
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
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MANNITOL
MEGLUMINE
POVIDONE K30
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (White or off-white to yellowish) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 1161
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-161-74 100 TABLET in 1 CARTON None
2 NDC:13668-161-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-161-72 30 TABLET in 1 CARTON None
4 NDC:13668-161-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201192 02/25/2014
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 864147745 manufacture (13668-159), manufacture (13668-160), manufacture (13668-161)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-159), manufacture (13668-160), manufacture (13668-161)

Revised: 03/2022 Torrent Pharmaceuticals Limited

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