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 86 of 200 · 3,987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD44768dd1-b132-c33b-e063-6294a90accd42025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
Gout Pain ManagementARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFForces of Nature9276fe9c-d9a2-4cef-986c-5d7d39f2d6a12025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Sterile alcohol padSTERILE ALCOHOL PADKingstar Medical (Xianning) Co., Ltd.39df5fc7-f66e-1605-e063-6394a90a00542025-11-24WarningsExact identifier
unii: ND2M416302
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Lymph HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALEEnergique, Inc.17aa9d9c-3d32-4963-91db-d1e96717e7ad2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
unii: ND2M416302
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 0E53J927NA
Pneumo SarcodeTEUCRIUM SCORODONIA, ARSENICUM IODATUM, LUNG (BOVINE), CALCAREA PHOSPHORICA, STANNUM METALLICUM, CARBO VEGETABILIS, PHELLANDRIUM AQUATICUM, SILICEA, SULPHURNutritional Specialties, Inc.c3a7cf75-723e-4fb9-8ff8-ae8f73a0900d2025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
SULWHASOO PERFECTING CUSHION NO. 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
unii: 15FIX9V2JP
CC Cream Broad Spectrum SPF 30 Merle NormanHOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc93ebe819-6763-400c-8320-812276168b6c2025-11-20WarningsExact identifier
unii: 15FIX9V2JP
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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