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 85 of 200 · 3,987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4528f48d-5bda-b307-e063-6294a90a294c2025-12-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Extra Strength Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.8064b01a-e049-4d49-a5b6-e72dbeb5daac2025-12-03WarningsExact identifier
unii: 0E53J927NA
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fbb53e-b547-0615-e053-2995a90a51512025-12-03WarningsExact identifier
unii: ND2M416302
The Green ScissorISOPROPYL ALCOHOL 99%The Green Scissor Incc1fb4069-b926-266b-e053-2995a90acab92025-12-03WarningsExact identifier
unii: ND2M416302
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8e6f9df1-0754-69e4-e053-2a95a90acc492025-12-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
CHLORAPREPCHLORAPREPHF Acquisition Co LLC, DBA HealthFirst44fe08e0-4e9c-8bd6-e063-6394a90a0e2b2025-12-02WarningsExact identifier
unii: ND2M416302
Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.44e7e28b-88e5-784b-e063-6294a90a60022025-12-01WarningsExact identifier
unii: 0E53J927NA
good neighbor pharmacy lansoprazoleLANSOPRAZOLEAmerisource Bergena4ee8db4-8f8e-4326-bd32-43abd53be8e42025-12-01WarningsExact identifier
unii: 0K5C5T2QPG
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
Walgreens Fast Acting Heartburn Relief Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.6eae97f3-a174-4cbc-badc-777475d2f7af2025-11-26WarningsExact identifier
unii: 0E53J927NA
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3 (CHOLECALCIFEROL) , CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIA CARBONICANutritional Specialties, Inc.4c86b348-5808-4d6d-b283-00ab37557fd72025-11-25WarningsExact identifier
unii: 0E53J927NA
FAST ACTING Heartburn ReliefALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.48c14005-811a-4868-b33e-9348455048562025-11-25WarningsExact identifier
unii: 0E53J927NA

Reported adverse events (FAERS/openFDA)#

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