Telmisartan (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462-199-13
Telmisartan Tablets USP20 mg

carton20mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462-200-13 Telmisartan Tablets USP40 mg

carton40mg
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462-201-13 Telmisartan Tablets USP80 mg

carton80mg
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TELMISARTAN telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-199
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEGLUMINE
POVIDONES
SODIUM HYDROXIDE
Product Characteristics
Color WHITE (to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code G;199
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-199-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-199-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68462-199-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090032 07/07/2014
TELMISARTAN telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 40 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEGLUMINE
POVIDONES
SODIUM HYDROXIDE
Product Characteristics
Color WHITE (to off-white) Score no score
Shape CAPSULE (capsule shaped) Size 12mm
Flavor Imprint Code G;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-200-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-200-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68462-200-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090032 07/07/2014
TELMISARTAN telmisartan tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN (TELMISARTAN) TELMISARTAN 80 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MEGLUMINE
POVIDONES
SODIUM HYDROXIDE
Product Characteristics
Color WHITE (to off-white) Score no score
Shape CAPSULE (capsule shaped) Size 16mm
Flavor Imprint Code G;201
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-201-01 100 TABLET in 1 BOTTLE None
2 NDC:68462-201-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68462-201-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090032 07/07/2014
Labeler — Glenmark Generics Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Ltd. 677318665 ANALYSIS (68462-199), ANALYSIS (68462-200), ANALYSIS (68462-201), MANUFACTURE (68462-199), MANUFACTURE (68462-200), MANUFACTURE (68462-201)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Ltd. 650283737 API MANUFACTURE (68462-199), API MANUFACTURE (68462-200), API MANUFACTURE (68462-201)

Revised: 01/2015 Glenmark Generics Inc., USA

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