Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Laboratorios Liconsa SAU
Xiromed, LLC
471409309
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole
Product Details
NDC Product Code
70700-150Application Number
ANDA212977Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 15, 2022Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
CrospovidoneInactive
Code: 2S7830E561Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6FClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
Polyethylene Glycol 6000Inactive
Code: 30IQX730WEClass: IACT
Polyvinyl Alcohol (100000 Mw)Inactive
Code: 949E52Z6MYClass: IACT
Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer (3:1; 45000 Mw)Inactive
Code: 23ZQ42JZZHClass: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Starch, CornInactive
Code: O8232NY3SJClass: IACT
AmmoniaInactive
Code: 5138Q19F1XClass: IACT
Raw SugarInactive
Code: 8M707QY5GHClass: IACT
Potassium HydroxideInactive
Code: WZH3C48M4TClass: IACT
Magnesium HydroxideInactive
Code: NBZ3QY004SClass: IACT
Omeprazole
Product Details
NDC Product Code
70700-149Application Number
ANDA212977Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 15, 2022OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 10 mg in 1 1
Magnesium HydroxideInactive
Code: NBZ3QY004SClass: IACT
CrospovidoneInactive
Code: 2S7830E561Class: IACT
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6FClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Raw SugarInactive
Code: 8M707QY5GHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357Class: IACT
Potassium HydroxideInactive
Code: WZH3C48M4TClass: IACT
AmmoniaInactive
Code: 5138Q19F1XClass: IACT
Starch, CornInactive
Code: O8232NY3SJClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
Polyethylene Glycol 6000Inactive
Code: 30IQX730WEClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Polyvinyl Alcohol (100000 Mw)Inactive
Code: 949E52Z6MYClass: IACT
Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer (3:1; 45000 Mw)Inactive
Code: 23ZQ42JZZHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT