Omeprazole
These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. INITIAL U.S. APPROVAL: 1989
Approved
Approval ID
40a75dc7-49b7-5c9d-6c5f-d4682ec6922e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-123
Application NumberANDA078490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (19)
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
OmeprazoleActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
meglumineInactive
Code: 6HG8UB2MUY
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
RAW SUGARInactive
Code: 8M707QY5GH
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Omeprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-634
Application NumberANDA078490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (19)
OmeprazoleActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
meglumineInactive
Code: 6HG8UB2MUY
Classification: IACT
RAW SUGARInactive
Code: 8M707QY5GH
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT