FDA.reportPublic FDA data

Omeclamox-Pak

Product NDC
66220-422
11-digit product format
662200422
Labeler code
66220
Product ID
66220-422_13c419e8-64ba-41d9-ae34-17ce8596bcd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole, clarithromycin, amoxicillin
Dosage form
KIT
Labeler
Cumberland Pharmaceuticals Inc.
Application
NDA050824
Marketing category
NDA
Marketing start
2012-04-27
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66220-422-012025-01-30C16284748780-12cef2736-610e-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use OMECLAMOX ® -PAK safely and effectively. See full prescribing information for OMECLAMOX-PAK. OMECLAMOX-PAK (omeprazole delayed-release capsules; clarithromycin tablets, amoxicillin capsules) co-packaged for oral use Initial U.S. Approval: 2011
66220-422-022025-01-30C16284748780-12cef2736-610e-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use OMECLAMOX ® -PAK safely and effectively. See full prescribing information for OMECLAMOX-PAK. OMECLAMOX-PAK (omeprazole delayed-release capsules; clarithromycin tablets, amoxicillin capsules) co-packaged for oral use Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66220-422-01Omeclamox-Pak1 in 1 BLISTER PACKKIT110
66220-422-02Omeclamox-Pak1 in 1 BLISTER PACKKIT110
66220-422-02Omeclamox-Pak10 in 1 CARTONKIT1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66220-422-01EA - Each66220-422b833ea72-dedb-44ac-a227-5d529600bc0d12016-12-07
66220-422-02EA - Each66220-4229e291c34-dc02-4432-9a32-a9125d589b5a12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66220-422OMECLAMOX-PAK (OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN) KIT [CUMBERLAND PHARMACEUTICALS INC.]10Legacy NDC, 3 package rows20230819_9e52c29a-fdbe-4a4d-b280-d700eba5b94f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291987{4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (omeprazole 20 MG Delayed Release Oral Capsule) } Pack [Omeclamox]BPCK9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
1291986{4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (omeprazole 20 MG Delayed Release Oral Capsule) } PackGPCK9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
308191amoxicillin 500 MG Oral CapsulePSN9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
1291986amoxicillin 500 MG Oral Capsule (4) / clarithromycin 500 MG Oral Tablet (2) / omeprazole 20 MG Delayed Release Oral Capsule (2) PackPSN9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
197517clarithromycin 500 MG Oral TabletPSN9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
1291987Omeclamox-PakPSN9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
308191amoxicillin 500 MG Oral CapsuleSCD9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
197517clarithromycin 500 MG Oral TabletSCD9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
1291987Omeclamox-PakSY9e52c29a-fdbe-4a4d-b280-d700eba5b94f10
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9e52c29a-fdbe-4a4d-b280-d700eba5b94f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66220-422-01662200422011 KIT in 1 BLISTER PACK (66220-422-01) 1 kit2012-04-270000-00-00NoNoCurrent
66220-422-026622004220210 BLISTER PACK in 1 CARTON (66220-422-02) > 1 KIT in 1 BLISTER PACK10 blister pack2012-04-270000-00-00NoNoCurrent