Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Prinston Pharmaceutical Inc.
967289799
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GENERICS BIDCO II, LLC
Solco healthcare U.S., LLC
Prinston Pharmaceutical Inc.
151228897
Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lisinopril
Product Details
NDC Product Code
43547-416Application Number
ANDA075743Marketing Category
ANDA (C73584)Route of Administration
OralEffective Date
September 20, 2018STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Lisinopril
Product Details
NDC Product Code
43547-419Application Number
ANDA075743Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2018DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIMQuantity: 40 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Lisinopril
Product Details
NDC Product Code
43547-414Application Number
ANDA075743Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2018LisinoprilActive
Code: E7199S1YWRClass: ACTIMQuantity: 2.5 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Lisinopril
Product Details
NDC Product Code
43547-418Application Number
ANDA075743Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2018LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 30 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Lisinopril
Product Details
NDC Product Code
43547-415Application Number
ANDA075743Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2018LisinoprilActive
Code: E7199S1YWRClass: ACTIMQuantity: 5 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Lisinopril
Product Details
NDC Product Code
43547-417Application Number
ANDA075743Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2018DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIMQuantity: 20 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT