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
Label	Manufacturer	Effective date	Type
Lansoprazole - Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2025-02-19	Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57237-001-14	2022-04-20	C162847	48780-1	9d75b9d0-f016-f424-e053-dadaa90a57ce	Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg Rx only
57237-001-14	2020-01-31	C162847	48780-1	9d75b9d0-f016-f424-e053-dadaa90a57ce	Lansoprazole 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-001-01	Lansoprazole, Amoxicillin, Clarithromycin	1 in 1 BLISTER PACK	KIT	1		13
57237-001-14	Lansoprazole, Amoxicillin, Clarithromycin	14 in 1 CARTON	KIT	14		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-001	LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN KIT [RISING PHARMA HOLDINGS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20250303_40adc1d3-7ce7-4698-aa7f-b5dbaaecec00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-001-01	EA - Each	57237-001	01b6981f-89ce-49c1-917d-2a9c12aae7c1	1	2016-12-07
57237-001-14	EA - Each	57237-001	fef45051-3218-445a-b742-a73b7e58fa0d	1	2016-11-08

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 129 of 197 · 3,925 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD	TITANIUM DIOXIDE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	ff95a7b7-3cb4-41b0-866d-69361354a0bc	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Golden	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a4c-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Light	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a948e37-0554-d953-e063-6394a90a75e6	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Fair	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a947e1d-286f-a939-e063-6394a90a0719	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Tan	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94a668-24cb-e0f2-e063-6294a90a79d3	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Medium	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a47-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a962944-9155-9b70-e063-6294a90ac535	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Medium	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a96811c-3ea6-15bc-e063-6394a90ac3bd	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Normal to Dry Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	414538d6-9108-54bf-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Colorstay Preo and Protect Primer	TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMER	Revlon Consumer Products Corp	8eebf23e-7fce-dfc0-e053-2995a90ae322	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon PhotoReady BB Cream Skin Perfector	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410ca372-4698-029d-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Oily to Combination Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410d1cb2-6c92-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
REVLON PHOTOREADY INSTA-FIX MAKEUP	TITANIUM DIOXIDE, ZINC OXIDE	Revlon Consumer Products Corp	442f2a06-47c0-2522-e054-00144ff88e88	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Youth FX	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	442dec1e-032c-28de-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup Medium	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a971e38-af63-e069-e063-6294a90a8f77	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	d9209277-469d-48f4-bf64-f39a70c19596	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup Light	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a987b85-efdb-eb95-e063-6394a90aef81	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Light	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a984dd9-7293-77f0-e063-6294a90a8f1e	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	ce1a4f32-da65-29d3-e053-2995a90a42ee	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 311277 unii: 0K5C5T2QPG
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c77da981-9260-fabd-e053-2a95a90aa71c	2024-12-31	Warnings, Adverse reactions	Exact identifier unii: 0K5C5T2QPG

Reported adverse events (FAERS/openFDA)#

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