TopCare Omeprazole delayed release
Topco Associates LLC. Omeprazole Delayed Release Tablets Drug Facts
Approved
Approval ID
31194780-c051-6d98-e063-6294a90a9a54
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 22, 2025
Manufacturers
FDA
Sixarp, LLC
DUNS: 016329513
FDA
Praxis, LLC
DUNS: 016329513
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 Code59368-325
Application NumberNDA022032
Product Classification
M
Marketing Category
C73594
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2025
FDA Product Classification
INGREDIENTS (20)
HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIEDInactive
Code: A7ZHS2RJ34
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
MONOETHANOLAMINEInactive
Code: 5KV86114PT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
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
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95N
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/30/2024
Package/Label Principal Display Panel
TopCare ®health
COMPARE TO PRILOSEC OTC ®
Omeprazole
DELAYED RELEASE TABLETS 20 mg
ACID REDUCER
24 HR
Treats Frequent Heartburn!
WILDBERRY MINT COATED TABLET
SWALLOW – DO NOT CHEW
actual size
14 TABLETS
ONE 14-DAY COURSE OF TREATMENT
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
