NDC Code(s) : 55700-479-30, 55700-479-60, 55700-479-90, 55700-480-30, 55700-480-90
Packager : Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LISINOPRILLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-479(NDC:43547-353)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL10 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (light pink) Score no score
Shape CAPSULE Size 8 mm
Flavor Imprint Code H;146
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-479-3030 in 1 BOTTLE Type 0: Not a Combination Product01/05/2018
2NDC:55700-479-6060 in 1 BOTTLE Type 0: Not a Combination Product01/05/2018
3NDC:55700-479-9090 in 1 BOTTLE Type 0: Not a Combination Product13/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076180 11/01/2011
LISINOPRILLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-480(NDC:43547-354)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL20 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (Dark Pink) Score no score
Shape CAPSULE Size 10 mm
Flavor Imprint Code H;147
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-480-3030 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
2NDC:55700-480-9090 in 1 BOTTLE Type 0: Not a Combination Product13/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076164 01/13/2017

LABELER - Quality Care Products LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Quality Care Products LLC 831276758 repack(55700-479, 55700-480)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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