NDC Code(s) : 0603-5914-20, 0603-5914-16, 0603-5914-32, 0603-5915-20, 0603-5915-16, 0603-5915-32, 0603-5916-20, 0603-5916-16, 0603-5916-32
Packager : Qualitest Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Telmisartan Telmisartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5914
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN20 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white colour) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code L202
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-5914-20100 in 1 CARTON Type 0: Not a Combination Product25/04/2015
2NDC:0603-5914-1630 in 1 BOTTLE Type 0: Not a Combination Product25/04/2015
3NDC:0603-5914-321000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202130 04/25/2015 02/28/2017
Telmisartan Telmisartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5915
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN40 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white colour) Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code L203
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-5915-20100 in 1 CARTON Type 0: Not a Combination Product25/04/2015
2NDC:0603-5915-1630 in 1 BOTTLE Type 0: Not a Combination Product25/04/2015
3NDC:0603-5915-321000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202130 04/25/2015 02/28/2017
Telmisartan Telmisartan TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5916
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN80 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE(UNII: FZ989GH94E)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white colour) Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code L204
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-5916-20100 in 1 CARTON Type 0: Not a Combination Product25/04/2015
2NDC:0603-5916-1630 in 1 BOTTLE Type 0: Not a Combination Product25/04/2015
3NDC:0603-5916-321000 in 1 BOTTLE Type 0: Not a Combination Product25/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202130 04/25/2015 03/31/2017

PRINCIPAL DISPLAY PANEL


Telmisartan Tablets, USP 20 mg (30 Tablets in 1 Bottle) 
Each tablet contains 20 mg of telmisartan USP
NDC 0603-5914-16


20 mg 30


PRINCIPAL DISPLAY PANEL

Telmisartan Tablets, USP 40 mg (30 Tablets in 1 Bottle)
Each tablet contains 40 mg of telmisartan USP
NDC 0603-5915-16


40 mg 30

PRINCIPAL DISPLAY PANEL

Telmisartan Tablets, USP 80 mg (30 Tablets in 1 Bottle)
Each tablet contains 80 mg of telmisartan USP
NDC 0603-5916-16


80 mg 30