FDA.reportPublic FDA data

NDC 57237-001-01 - Lansoprazole, Amoxicillin, Clarithromycin

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
57237-001
Requested NDC
57237-001-01
Package NDCs from labels
57237-001-01, 57237-001-14
Manufacturer
Rising Pharma Holdings, Inc. | Aurobindo Pharma Limited
Effective date
2025-02-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lansoprazole - Rising Pharma Holdings, Inc. | Aurobindo Pharma LimitedRising Pharma Holdings, Inc. | Aurobindo Pharma Limited2025-02-19Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57237-001-142022-04-20C16284748780-19d75b9d0-f016-f424-e053-dadaa90a57ceLansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only
57237-001-142020-01-31C16284748780-19d75b9d0-f016-f424-e053-dadaa90a57ceLansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-001-01Lansoprazole, Amoxicillin, Clarithromycin1 in 1 BLISTER PACKKIT113
57237-001-14Lansoprazole, Amoxicillin, Clarithromycin14 in 1 CARTONKIT1413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-001LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN KIT [RISING PHARMA HOLDINGS, INC.]13Current NDC, Legacy NDC, 2 package rows20250303_40adc1d3-7ce7-4698-aa7f-b5dbaaecec00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-001-01EA - Each57237-00101b6981f-89ce-49c1-917d-2a9c12aae7c112016-12-07
57237-001-14EA - Each57237-001fef45051-3218-445a-b742-a73b7e58fa0d12016-11-08

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 9 of 200 · 3,987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLERedpharm Drug56cafcf5-ce3d-a312-e063-6294a90a3db12026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 311277
unii: 0K5C5T2QPG
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.18a4f555-a537-4c40-9bb2-dc3bd782fa272026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
LansoprazoleLANSOPRAZOLERugby Laboratories, Incaa95216c-8985-d160-1743-ba168a35177f2026-07-17WarningsExact identifier
unii: 0K5C5T2QPG
VOQUEZNA DUAL PAKVONOPRAZAN FUMARATE AND AMOXICILLINPhathom Pharmaceuticals Inc.0cb2ee04-8581-46c8-a781-7be170ab5c862026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 197517
rxcui: 308191
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.1127a41b-14a1-4fe8-ae37-67ea5d7603012026-07-16Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.a24acc0b-7770-1087-77bd-048259a5bf722026-07-15WarningsExact identifier
unii: 0K5C5T2QPG
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.6e1c6209-660f-4043-b6a6-eac5f7665ef92026-07-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.ad804b34-169c-44bf-a469-f1149433d96b2026-07-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
LansoprazoleLANSOPRAZOLELEADER/ Cardinal Health 110, Inc.486838cd-17ee-c2df-4e05-aa6106dd8fd82026-07-15WarningsExact identifier
unii: 0K5C5T2QPG
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
unii: 0E53J927NA
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHAWAII REPACK, INC.7fb0f56e-c098-49e4-b075-2eb8936582aa2026-07-13Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Alcohol Cleansing WipeISOPROPYL ALCOHOLHubei Fanjian Medical Product Co.,Ltd1607fb06-826b-42bb-986e-0023a1b078f32026-07-10WarningsExact identifier
unii: ND2M416302
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Limited15e05eda-48aa-a4b7-4b8a-4ee1cf1101202026-07-09WarningsExact identifier
unii: 0K5C5T2QPG
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.96057ce7-9516-4239-9974-5e9691b44c9b2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthwind Health Company, LLC1d0d8bc4-137e-ef10-e063-6294a90acf622026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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