Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct Rx
Direct Rx
079254320
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OMEPRAZOLE DR
Product Details
NDC Product Code
61919-176Application Number
ANDA076048Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2023MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004SClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
OMEPRAZOLE DR
Product Details
NDC Product Code
61919-773Application Number
ANDA076048Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2023FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004SClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT
OMEPRAZOLE
Product Details
NDC Product Code
61919-847Application Number
ANDA091672Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2023GELATINInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT