NDC Code 58118-1520-8 - Hydrochlorothiazide

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg
LISINOPRIL(UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)	LISINOPRIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58118-0519-9	90 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013
2	NDC:58118-0519-3	30 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013
3	NDC:58118-0519-8	30 in 1 BLISTER PACK Type 0: Not a Combination Product	18/10/2013
4	NDC:58118-0519-0	1 in 1 PACKAGE Type 0: Not a Combination Product	18/10/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077912	04/10/2006	06/23/2017

LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25 mg
LISINOPRIL(UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)	LISINOPRIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58118-1520-9	90 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013
2	NDC:58118-1520-3	30 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013
3	NDC:58118-1520-8	30 in 1 BLISTER PACK Type 0: Not a Combination Product	18/10/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077912	04/10/2006	06/23/2017

LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	12.5 mg
LISINOPRIL(UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)	LISINOPRIL	10 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ALUMINUM OXIDE(UNII: LMI26O6933)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58118-1518-9	90 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013
2	NDC:58118-1518-3	30 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013
3	NDC:58118-1518-6	60 in 1 BOTTLE Type 0: Not a Combination Product	18/10/2013