Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dr. Reddy's Laboratories Limited- FTO3
NorthStar Rx LLC
918608162
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
16714-123Application Number
ANDA078490Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 15, 2023glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 40 mg in 1 1
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
meglumineInactive
Code: 6HG8UB2MUYClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
RAW SUGARInactive
Code: 8M707QY5GHClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
gelatinInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Omeprazole
Product Details
NDC Product Code
16714-634Application Number
ANDA078490Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 15, 2023OmeprazoleActive
Code: KG60484QX9Class: ACTIBQuantity: 20 mg in 1 1
glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
meglumineInactive
Code: 6HG8UB2MUYClass: IACT
RAW SUGARInactive
Code: 8M707QY5GHClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
triethyl citrateInactive
Code: 8Z96QXD6UMClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
gelatinInactive
Code: 2G86QN327LClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT