careone omeprazole
Retail Business Services, LLC. Omeprazole Drug Facts
Approved
Approval ID
063cfad8-3ca6-4b72-a4c9-512b8047bae3
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Retail Business Services, LLC
DUNS: 967989935
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 Code72476-473
Application NumberNDA022032
Product Classification
M
Marketing Category
C73594
G
Generic Name
omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (17)
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
SODIUM STEARATEInactive
Code: QU7E2XA9TG
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIEDInactive
Code: A7ZHS2RJ34
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MONOETHANOLAMINEInactive
Code: 5KV86114PT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/17/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 11/4/2021
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 11/4/2021
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 11/4/2021
WARNINGS SECTION
LOINC: 34071-1Updated: 4/17/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 11/4/2021
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 4/17/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 11/4/2021
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 4/17/2025