NDC Code(s) : 0603-5926-16, 0603-5926-32, 0603-5926-20, 0603-5927-16, 0603-5927-32, 0603-5927-20, 0603-5928-16, 0603-5928-32, 0603-5928-20
Packager : Qualitest Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5926
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN40 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE K25(UNII: K0KQV10C35)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color WHITE (WHITE to OFF-WHITE), PINK Score no score
Shape OVAL (OBLONG) Size 14 mm
Flavor Imprint Code L199
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-5926-1630 in 1 BOTTLE Type 0: Not a Combination Product27/02/2014
2NDC:0603-5926-321000 in 1 BOTTLE Type 0: Not a Combination Product27/02/2014
3NDC:0603-5926-20100 in 1 CARTON Type 0: Not a Combination Product27/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203010 02/27/2014 08/31/2017
Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5927
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN80 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE K25(UNII: K0KQV10C35)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color WHITE (WHITE to OFF-WHITE), PINK Score no score
Shape OVAL (OBLONG) Size 16 mm
Flavor Imprint Code L200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-5927-1630 in 1 BOTTLE Type 0: Not a Combination Product27/02/2014
2NDC:0603-5927-321000 in 1 BOTTLE Type 0: Not a Combination Product27/02/2014
3NDC:0603-5927-20100 in 1 CARTON Type 0: Not a Combination Product27/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203010 02/27/2014 09/30/2017
Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5928
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TELMISARTAN(UNII: U5SYW473RQ)
(TELMISARTAN - UNII:U5SYW473RQ) 		TELMISARTAN80 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MEGLUMINE(UNII: 6HG8UB2MUY)
POVIDONE K25(UNII: K0KQV10C35)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color WHITE (WHITE to OFF-WHITE), YELLOW Score no score
Shape OVAL (OBLONG) Size 16 mm
Flavor Imprint Code L201
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-5928-1630 in 1 BOTTLE Type 0: Not a Combination Product27/02/2014
2NDC:0603-5928-321000 in 1 BOTTLE Type 0: Not a Combination Product27/02/2014
3NDC:0603-5928-20100 in 1 CARTON Type 0: Not a Combination Product27/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203010 02/27/2014 08/31/2017

PRINCIPAL DISPLAY PANEL


Telmisartan and Hydrochlorothiazide Tablets 40 mg/12.5 mg (30 Tablets in 1 Bottle)
Each tablet contains 40 mg of telmisartan USP and 12.5 mg of hydrochlorothiazide USP
0603-5926-16 



40 mg 12.5 mg 30








PRINCIPAL DISPLAY PANEL

Telmisartan and Hydrochlorothiazide Tablets 80 mg/12.5 mg (30 Tablets in 1 Bottle)
Each tablet contains 80 mg of telmisartan USP and 12.5 mg of hydrochlorothiazide USP
0603-5927-16


80 mg 12.5 mg 30

PRINCIPAL DISPLAY PANEL

Telmisartan and Hydrochlorothiazide Tablets 80 mg/25 mg (30 Tablets in 1 Bottle)
Each tablet contains 80 mg of telmisartan USP and 25 mg of hydrochlorothiazide USP
0603-5928-16


80 mg 25 mg 30