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 8 of 200 · 3,987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
GLP-4TE HOMOAACG-A, AACG-B, ADENOSINUM CYCLOPHOSPHORICUM, BERBERINUM, CALCAREA CARBONICA, CINCHONA OFFICINALIS, CHOLINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, CURCUMA LONGA, METHYLCOBALAMIN, DNA, FERRUM METALLICUM, PANAX GINSENG, L-GLUTAMIC ACID, HEPAR SUIS, HYPOTHALAMUS SUIS, INDOLUM, INSULINUM (HUMAN), IODIUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, L-METHIONINE, PANCREAS SUIS, STOMACH (SUIS), ZINCUM METALLICUM, 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATEDeseret Biologicals, Inc.bb41a08a-e960-4364-a547-4ad356b2c36d2026-07-24WarningsExact identifier
unii: 0E53J927NA
DOCTOR INKS IPA WIPESISOPROPYL ALCOHOLEnviro Specialty Chemicals Incf65f0ec4-fa2c-487d-a8cc-41cbb8c140a42026-07-24WarningsExact identifier
unii: ND2M416302
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMChartwell RX, LLC00b86913-50c8-443f-8467-f4f499d358af2026-07-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
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
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
unii: ND2M416302
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
unii: ND2M416302
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
AmoxicillinAMOXICILLINREMEDYREPACK INC.102c62ca-da20-4866-84a8-e3513824af4a2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.4a701c0d-fef5-aa12-01e6-e3680a161a7d2026-07-21WarningsExact identifier
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
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
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
unii: ND2M416302
AmoxicillinAMOXICILLINHAWAII REPACK, INC.bf130964-8386-4ab7-8d3b-fb0174670afc2026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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