FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
42571-161
11-digit product format
425710161
Labeler code
42571
Product ID
42571-161_3a71d6d7-6111-a0f8-e063-6394a90aa0e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA205707
Marketing category
ANDA
Marketing start
2017-03-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500; 125 mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMOXICILLIN AND CLAVULANATE POTASSIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42571-161-012020-07-29C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-012020-07-29C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-112020-07-29C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-112020-07-29C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-422020-07-29C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-422020-07-29C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-012020-07-22C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-012020-07-22C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-112020-07-22C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-112020-07-22C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-422020-07-22C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-161-422020-07-22C16284748780-1ab0e2407-331c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-161-01AMOXICILLIN AND CLAVULANATE POTASSIUM100 in 1 BOTTLETABLET, FILM COATED10025
42571-161-11AMOXICILLIN AND CLAVULANATE POTASSIUM10 in 1 CARTONTABLET, FILM COATED1025
42571-161-32AMOXICILLIN AND CLAVULANATE POTASSIUM10 in 1 BLISTER PACKTABLET, FILM COATED1025
42571-161-42AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, FILM COATED2025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-161-01EA - Each42571-1612290a273-7417-4c76-a321-c04dc91332ed12017-09-11
42571-161-42EA - Each42571-1611f04e5ca-d78a-44b7-b855-66e43fad8eed12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-161AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED [MICRO LABS LIMITED]24Current NDC, Legacy NDC, 4 package rows20240927_0c2d1fbc-f80c-4737-a15e-9cfa6bf99769.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNb5e66987-09e3-45b2-88ba-59c8647d724e100
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNd7c0a364-d5d1-432d-823b-844a2d0b6780100
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDb5e66987-09e3-45b2-88ba-59c8647d724e100
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDd7c0a364-d5d1-432d-823b-844a2d0b6780100
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd7c0a364-d5d1-432d-823b-844a2d0b6780100
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYb5e66987-09e3-45b2-88ba-59c8647d724e100
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY0c2d1fbc-f80c-4737-a15e-9cfa6bf9976925
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN6e1c6209-660f-4043-b6a6-eac5f7665ef920
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD6e1c6209-660f-4043-b6a6-eac5f7665ef920
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6e1c6209-660f-4043-b6a6-eac5f7665ef920
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNf17fddd3-aecc-456c-9b2b-f33b7fdb353e6
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN56fb634c-3725-4d0a-8f20-584652a1d99f6
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDf17fddd3-aecc-456c-9b2b-f33b7fdb353e6
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD56fb634c-3725-4d0a-8f20-584652a1d99f6
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf17fddd3-aecc-456c-9b2b-f33b7fdb353e6
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY56fb634c-3725-4d0a-8f20-584652a1d99f6
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN643d3a2d-374d-b0c1-e053-2991aa0aae0b5
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD643d3a2d-374d-b0c1-e053-2991aa0aae0b5
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY643d3a2d-374d-b0c1-e053-2991aa0aae0b5
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN73932845-d907-4846-e053-2a91aa0a9e724
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN64a27ad7-4d32-69c8-e053-2a91aa0aa9674
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN6542fa18-6219-602f-e053-2991aa0a54d04
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN6635fda2-15c3-2ff5-e053-2991aa0a5abb4
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD64a27ad7-4d32-69c8-e053-2a91aa0aa9674
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD73932845-d907-4846-e053-2a91aa0a9e724
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD6635fda2-15c3-2ff5-e053-2991aa0a5abb4
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD6542fa18-6219-602f-e053-2991aa0a54d04
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6635fda2-15c3-2ff5-e053-2991aa0a5abb4
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6542fa18-6219-602f-e053-2991aa0a54d04
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY64a27ad7-4d32-69c8-e053-2a91aa0aa9674
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY73932845-d907-4846-e053-2a91aa0a9e724
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN6c9475e4-e359-4fa9-a491-6b1641f5944f3
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD6c9475e4-e359-4fa9-a491-6b1641f5944f3
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6c9475e4-e359-4fa9-a491-6b1641f5944f3
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN1275ad58-c53f-20d0-e063-6394a90a4a431
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN513b6211-c73b-7e66-e063-6394a90a2aa11
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN3b4f868d-6a3e-8276-e063-6294a90a64571
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD1275ad58-c53f-20d0-e063-6394a90a4a431
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD3b4f868d-6a3e-8276-e063-6294a90a64571
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD513b6211-c73b-7e66-e063-6394a90a2aa11
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY3b4f868d-6a3e-8276-e063-6294a90a64571
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1275ad58-c53f-20d0-e063-6394a90a4a431
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY513b6211-c73b-7e66-e063-6394a90a2aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-161-0142571016101100 TABLET, FILM COATED in 1 BOTTLE (42571-161-01) 2017-03-010000-00-00NoNoCurrent
42571-161-114257101611110 BLISTER PACK in 1 CARTON (42571-161-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-161-32) 10 blister pack2017-03-010000-00-00NoNoCurrent
42571-161-324257101613210 in 1 BLISTER PACKHistorical
42571-161-424257101614220 TABLET, FILM COATED in 1 BOTTLE (42571-161-42) 2017-03-010000-00-00NoNoCurrent