Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ascent Pharmaceuticals, Inc
Exelan Pharmaceuticals Inc.
080938961
InvaGen Pharmaceuticals, Inc
Exelan Pharmaceuticals Inc.
080334903
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
76282-421Application Number
ANDA203508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2020STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 30 mg in 1 1
lisinopril
Product Details
NDC Product Code
76282-420Application Number
ANDA203508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2020LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
lisinopril
Product Details
NDC Product Code
76282-422Application Number
ANDA203508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2020LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 40 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
lisinopril
Product Details
NDC Product Code
76282-419Application Number
ANDA203508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2020STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
lisinopril
Product Details
NDC Product Code
76282-417Application Number
ANDA203508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2020STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 2.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
lisinopril
Product Details
NDC Product Code
76282-418Application Number
ANDA203508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2020STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT