NDC Code(s) : 58118-0519-9, 58118-0519-3, 58118-0519-8, 58118-0519-0, 58118-1520-9, 58118-1520-3, 58118-1520-8, 58118-1518-9, 58118-1518-3, 58118-1518-6
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0519(NDC:68180-519)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code LL;B02
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0519-990 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:58118-0519-330 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
3NDC:58118-0519-830 in 1 BLISTER PACK Type 0: Not a Combination Product18/10/2013
4NDC:58118-0519-01 in 1 PACKAGE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077912 04/10/2006 06/23/2017
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-1520(NDC:68180-520)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color orange Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code LL;B03
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-1520-990 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:58118-1520-330 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
3NDC:58118-1520-830 in 1 BLISTER PACK Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077912 04/10/2006 06/23/2017
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-1518(NDC:68180-518)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE12.5 mg
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color blue Score no score
Shape HEXAGON (6 sided) Size 7 mm
Flavor Imprint Code LL;B01
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-1518-990 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
2NDC:58118-1518-330 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
3NDC:58118-1518-660 in 1 BOTTLE Type 0: Not a Combination Product18/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077912 04/10/2006 06/23/2017

PRINCIPAL DISPLAY PANEL

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP

LisHCTZ20.12.5Lab0

PRINCIPAL DISPLAY PANEL

LisHCTZ20.12.5Lab3.jpg

PRINCIPAL DISPLAY PANEL

LisHCTZ20.12.5Lab8.jpg

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

LisHCTZ20.25Lab3

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LisHCTZ20.25Lab6

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LisHCTZ20.25Lab9

PRINCIPAL DISPLAY PANEL

LisHCTZ10.12.5Lab3

PRINCIPAL DISPLAY PANEL

LisHCTZ10.12.5Lab6

PRINCIPAL DISPLAY PANEL

LisHCTZ10.12.5Lab9