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 133 of 197 · 3,925 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b1f9a-34fd-cb50-e063-6394a90af9252024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SANDOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b3236-3f3d-c9e8-e063-6394a90a74432024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNYOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC299b416d-ce02-3462-e063-6294a90a38f02024-12-19WarningsExact identifier
unii: 15FIX9V2JP
PuttisuTITANIUM DIOXIDE, ZINC OXIDEJellycup, Inc.a032331a-6724-d2cd-e053-2995a90ac15a2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
ISOPROPYL RUBBING ALCOHOL 99% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsd196bef3-625a-b7d5-e053-2995a90afe6c2024-12-19WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLHome Smart Productscfe4fca2-bb20-4ab3-b304-32d9ba0451f62024-12-19WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHome Smart Products9cc0767c-b9aa-42c1-b183-a35f2560942b2024-12-19WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf159051c-27de-52a9-e053-2995a90aeb722024-12-19WarningsExact identifier
unii: ND2M416302
91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf15a6843-78bd-223c-e053-2a95a90a20332024-12-19WarningsExact identifier
unii: ND2M416302
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf158ad51-b772-257f-e053-2a95a90a55582024-12-19WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsce735a5f-0502-44ca-b2d6-db97ad0c01cb2024-12-19WarningsExact identifier
unii: ND2M416302
AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORT USA INC8e52e75f-717a-4829-b1aa-f35cf1981af82024-12-19WarningsExact identifier
unii: ND2M416302
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHome Smart Productsd1601184-c38c-79eb-e053-2a95a90aba502024-12-19WarningsExact identifier
unii: ND2M416302
toty Ilumina CC Cream 1NTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe4efe14e-7d46-78c0-e053-2995a90a23642024-12-19WarningsExact identifier
unii: 15FIX9V2JP
germstar Original unscentedISOPROPYL ALCOHOLSoaptronic, LLCda14d588-a9f7-4796-a532-20156afc100f2024-12-19WarningsExact identifier
unii: ND2M416302
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMELOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a82ba9-c0f8-0edf-e063-6294a90a50b42024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a8812b-70ff-e8aa-e063-6294a90a09f82024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Neutral DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.3a548deb-3670-4c5b-a139-796701801fed2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Olive Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.be4434c0-cbdd-46cb-8015-4c7859e80d4a2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Golden MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.de50e956-a014-4147-922b-63c95fa6f86b2024-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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