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 91 of 200 · 3,987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d690d5d1-e1fa-404f-a17e-7b97be17b44a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2fbdeff7-4880-49ef-bb4d-e033d18e04592025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6a86e5fd-6736-45e0-aa7d-d268fdaed4f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.42a3625f-5c58-4ec5-895f-b14f744282712025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8e14fe81-cf7f-4a81-afec-e6c8466179c92025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.7dd9f4cb-78d8-4edc-a63c-d4a02930a0f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Pocket NurseISOPROPYL ALCOHOLPocket Nurse Enterprises, LLC42ded32e-15d9-8b03-e063-6394a90ad6bc2025-11-06WarningsExact identifier
unii: ND2M416302
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
unii: 15FIX9V2JP
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack22cd4e96-2288-470c-9264-8058cd7db9b02025-11-05Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETARGET CORPORATION3d987f0b-4d7e-489e-ab19-efe1ee11009a2025-11-04WarningsExact identifier
unii: 0E53J927NA
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85291b2b-40b9-07fa-e053-2a91aa0a84e42025-11-04WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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