FDA.reportPublic FDA data

NDC 57483-840-01 - omeprazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57483-840
Requested NDC
57483-840-01
Package NDCs from labels
57483-840-01, 57483-840-42
Manufacturer
INNOVUS PHARMACEUTICALS, INC. | Sun Pharmaceutical Industries Limited
Effective date
2024-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsINNOVUS PHARMACEUTICALS, INC. | Sun Pharmaceutical Industries Limited2024-10-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-840-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
57483-840-42omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-840OMEPRAZOLE TABLET, DELAYED RELEASE [INNOVUS PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20241116_7535a309-1a67-4f50-911b-7cf570322931.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 130 · 2,585 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OTTFFSS SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4e76504b-82da-e7a4-e063-6294a90a4f812026-07-30WarningsExact identifier
unii: 5138Q19F1X
Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing Company37291cab-e350-d8e3-e063-6294a90a9cb12026-07-29WarningsExact identifier
rxcui: 402014
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
REINREUDE SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4c29c7f0-0d34-40bd-e063-6294a90a6ca72026-07-24WarningsExact identifier
unii: 5138Q19F1X
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
SERYNTH SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4a4be985-7de7-4eba-e063-6394a90ac84e2026-07-21WarningsExact identifier
unii: 5138Q19F1X
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Lepnuns SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD497f5bd0-b913-706b-e063-6394a90abf302026-07-20WarningsExact identifier
unii: 5138Q19F1X
WXMX Smelling SaltsAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD49927820-1862-4792-e063-6294a90acf9e2026-07-20WarningsExact identifier
unii: 5138Q19F1X
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
OmeprazoleOMEPRAZOLEP & L Development, LLC883e428a-e157-4bbf-8657-e7a93dc99e8c2026-07-14WarningsExact identifier
rxcui: 402014
OmeprazoleOMEPRAZOLEWALMART INC. (see also Equate)d3c1ba08-680d-4e39-875c-1f1d42ae787c2026-07-13WarningsExact identifier
rxcui: 402014