FDA.reportPublic FDA data

NDC 68196-045-01 - Lansoprazole

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
68196-045
Requested NDC
68196-045-01
Package NDCs from labels
68196-045-01, 68196-045-03
Manufacturer
Sam's West Inc. | Legacy Pharmaceutical Packaging, LLC
Effective date
2025-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lansoprazole - Sam's West Inc. | Legacy Pharmaceutical Packaging, LLCSam's West Inc. | Legacy Pharmaceutical Packaging, LLC2025-02-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-045-01Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE1414
68196-045-03Lansoprazole3 in 1 PACKAGECAPSULE, DELAYED RELEASE314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-045LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAM'S WEST INC.]142 package rows20250207_facbdcdc-e75d-d7ef-e053-6394a90a7833.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 3 of 116 · 2,316 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.4a701c0d-fef5-aa12-01e6-e3680a161a7d2026-07-21WarningsExact identifier
application number: ANDA202194
rxcui: 596843
unii: 0K5C5T2QPG
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
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
LansoprazoleLANSOPRAZOLERedpharm Drug56cafcf5-ce3d-a312-e063-6294a90a3db12026-07-17Warnings, Adverse reactionsExact identifier
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLERugby Laboratories, Incaa95216c-8985-d160-1743-ba168a35177f2026-07-17WarningsExact identifier
application number: ANDA202194
rxcui: 596843
unii: 0K5C5T2QPG
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.a24acc0b-7770-1087-77bd-048259a5bf722026-07-15WarningsExact identifier
application number: ANDA202194
rxcui: 596843
unii: 0K5C5T2QPG
LansoprazoleLANSOPRAZOLELEADER/ Cardinal Health 110, Inc.486838cd-17ee-c2df-4e05-aa6106dd8fd82026-07-15WarningsExact identifier
application number: ANDA202194
rxcui: 596843
unii: 0K5C5T2QPG
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
unii: 0E53J927NA
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Limited15e05eda-48aa-a4b7-4b8a-4ee1cf1101202026-07-09WarningsExact identifier
application number: ANDA202194
ndc (product): 55111-739
rxcui: 596843
spl id: 06355b28-9bb0-baea-0f4b-f1e4f7e670b6
spl set id: 15e05eda-48aa-a4b7-4b8a-4ee1cf110120
unii: 0K5C5T2QPG
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
careone acid reducerLANSOPRAZOLERetail Business Services, LLCe6b42dec-3545-483f-97db-9375b3732fba2026-07-08WarningsExact identifier
rxcui: 596843
unii: 0K5C5T2QPG
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.