NDC Code 0603-5927-16 - Hydrochlorothiazide

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TELMISARTAN(UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	40 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0603-5926-16	30 in 1 BOTTLE Type 0: Not a Combination Product	27/02/2014
2	NDC:0603-5926-32	1000 in 1 BOTTLE Type 0: Not a Combination Product	27/02/2014
3	NDC:0603-5926-20	100 in 1 CARTON Type 0: Not a Combination Product	27/02/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203010	02/27/2014	08/31/2017

Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TELMISARTAN(UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	80 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0603-5927-16	30 in 1 BOTTLE Type 0: Not a Combination Product	27/02/2014
2	NDC:0603-5927-32	1000 in 1 BOTTLE Type 0: Not a Combination Product	27/02/2014
3	NDC:0603-5927-20	100 in 1 CARTON Type 0: Not a Combination Product	27/02/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203010	02/27/2014	09/30/2017

Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TELMISARTAN(UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	80 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0603-5928-16	30 in 1 BOTTLE Type 0: Not a Combination Product	27/02/2014
2	NDC:0603-5928-32	1000 in 1 BOTTLE Type 0: Not a Combination Product	27/02/2014
3	NDC:0603-5928-20	100 in 1 CARTON Type 0: Not a Combination Product	27/02/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203010	02/27/2014	08/31/2017

NDC 0603-5927-16
API & Excipient Details