omeprazole
Omeprazole Drug Facts
Approved
Approval ID
cb47354c-297b-4dc2-85af-242acc967b56
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 6, 2025
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
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 Code45802-888
Application NumberNDA022032
Product Classification
M
Marketing Category
C73594
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2025
FDA Product Classification
INGREDIENTS (16)
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIEDInactive
Code: A7ZHS2RJ34
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MONOETHANOLAMINEInactive
Code: 5KV86114PT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SODIUM STEARATEInactive
Code: QU7E2XA9TG
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT