FDA.reportPublic FDA data

Lansoprazole, Amoxicillin, Clarithromycin

Product NDC
57237-001
11-digit product format
572370001
Labeler code
57237
Product ID
57237-001_bca6d415-61f6-4758-91fc-964d1e40c81b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole, Amoxicillin, Clarithromycin
Dosage form
KIT
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206006
Marketing category
ANDA
Marketing start
2016-10-14
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole, Amoxicillin, Clarithromycin
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui197517, 308191, 311277, 757968

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757968{4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) } PackGPCK40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
7579684 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) PackPSN40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
308191amoxicillin 500 MG Oral CapsulePSN40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
197517clarithromycin 500 MG Oral TabletPSN40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
308191amoxicillin 500 MG Oral CapsuleSCD40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
197517clarithromycin 500 MG Oral TabletSCD40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY40adc1d3-7ce7-4698-aa7f-b5dbaaecec0013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-001-01572370001011 in 1 BLISTER PACKHistorical
57237-001-145723700011414 BLISTER PACK in 1 CARTON (57237-001-14) / 1 KIT in 1 BLISTER PACK (57237-001-01) 14 blister pack2016-10-140000-00-00NoNoCurrent