FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
42571-162
11-digit product format
425710162
Labeler code
42571
Product ID
42571-162_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
ANDA204755
Marketing category
ANDA
Marketing start
2017-03-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 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
AMOXICILLIN875 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
42571-162-012020-07-29C16284748780-1ab0e2407-331c-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
42571-162-012020-07-29C16284748780-1ab0e2407-331c-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
42571-162-422020-07-29C16284748780-1ab0e2407-331c-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
42571-162-422020-07-29C16284748780-1ab0e2407-331c-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
42571-162-442020-07-29C16284748780-1ab0e2407-331c-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
42571-162-442020-07-29C16284748780-1ab0e2407-331c-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
42571-162-012020-07-22C16284748780-1ab0e2407-331c-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
42571-162-012020-07-22C16284748780-1ab0e2407-331c-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
42571-162-422020-07-22C16284748780-1ab0e2407-331c-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
42571-162-422020-07-22C16284748780-1ab0e2407-331c-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
42571-162-442020-07-22C16284748780-1ab0e2407-331c-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
42571-162-442020-07-22C16284748780-1ab0e2407-331c-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
42571-162-01AMOXICILLIN AND CLAVULANATE POTASSIUM100 in 1 BOTTLETABLET, FILM COATED10025
42571-162-42AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, FILM COATED2025
42571-162-43AMOXICILLIN AND CLAVULANATE POTASSIUM4 in 1 BLISTER PACKTABLET, FILM COATED425
42571-162-44AMOXICILLIN AND CLAVULANATE POTASSIUM4 in 1 CARTONTABLET, FILM COATED425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-162-01EA - Each42571-1624b91eaac-e2d6-4c19-953c-feebeb52571812017-09-11
42571-162-42EA - Each42571-162fa7d7480-6d23-4e16-aafe-d050058d98fd12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-162AMOXICILLIN 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
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN9bd9e662-0b80-45a8-906b-3dc04ee6b3ba101
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD9bd9e662-0b80-45a8-906b-3dc04ee6b3ba101
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9bd9e662-0b80-45a8-906b-3dc04ee6b3ba101
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNeef98beb-57d9-448a-b89c-6acd6f7b443e100
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDeef98beb-57d9-448a-b89c-6acd6f7b443e100
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYeef98beb-57d9-448a-b89c-6acd6f7b443e100
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
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa26f2ceb-bb9b-4813-9691-63433818686021
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa26f2ceb-bb9b-4813-9691-63433818686021
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa26f2ceb-bb9b-4813-9691-63433818686021
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNe153a542-3a3c-48ff-84cf-970832d4e8477
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN89092bb8-6a1c-e23e-e053-2a95a90aa7507
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD89092bb8-6a1c-e23e-e053-2a95a90aa7507
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDe153a542-3a3c-48ff-84cf-970832d4e8477
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY89092bb8-6a1c-e23e-e053-2a95a90aa7507
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYe153a542-3a3c-48ff-84cf-970832d4e8477
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNda5bfc31-5431-49b4-b21b-619712ab43a76
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN6285c4f2-c13b-49a9-e053-2991aa0a2b036
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNd294e4a2-8ce7-418d-e053-2a95a90ab10b6
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD6285c4f2-c13b-49a9-e053-2991aa0a2b036
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDda5bfc31-5431-49b4-b21b-619712ab43a76
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDd294e4a2-8ce7-418d-e053-2a95a90ab10b6
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYda5bfc31-5431-49b4-b21b-619712ab43a76
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd294e4a2-8ce7-418d-e053-2a95a90ab10b6
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6285c4f2-c13b-49a9-e053-2991aa0a2b036
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7526a33a-18d6-36ca-e053-2a91aa0ab9f95
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7526a33a-18d6-36ca-e053-2a91aa0ab9f95
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7526a33a-18d6-36ca-e053-2a91aa0ab9f95
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNe08c1bee-14c8-4bd1-898c-1874251dadf84
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNfbd40fcd-bf5b-e91e-e053-6394a90a609c4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN6d0c9ea1-aef8-5afe-e053-2991aa0a9e3e4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN75d87146-e38c-0428-e053-2991aa0aeff84
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDfbd40fcd-bf5b-e91e-e053-6394a90a609c4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD75d87146-e38c-0428-e053-2991aa0aeff84
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD6d0c9ea1-aef8-5afe-e053-2991aa0a9e3e4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDe08c1bee-14c8-4bd1-898c-1874251dadf84
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYfbd40fcd-bf5b-e91e-e053-6394a90a609c4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY75d87146-e38c-0428-e053-2991aa0aeff84
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYe08c1bee-14c8-4bd1-898c-1874251dadf84
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6d0c9ea1-aef8-5afe-e053-2991aa0a9e3e4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN1069b873-9bf9-cb22-e063-6394a90a4feb3
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN748d92d8-e832-475a-bff8-5435a34996b33
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD748d92d8-e832-475a-bff8-5435a34996b33
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD1069b873-9bf9-cb22-e063-6394a90a4feb3
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY748d92d8-e832-475a-bff8-5435a34996b33
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1069b873-9bf9-cb22-e063-6394a90a4feb3
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN12a00e7e-80f5-7c5e-e063-6394a90a68d21
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNbf29327f-4e43-4597-83d2-f64349bf9d9a1
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD12a00e7e-80f5-7c5e-e063-6394a90a68d21
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDbf29327f-4e43-4597-83d2-f64349bf9d9a1
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY12a00e7e-80f5-7c5e-e063-6394a90a68d21
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYbf29327f-4e43-4597-83d2-f64349bf9d9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-162-0142571016201100 TABLET, FILM COATED in 1 BOTTLE (42571-162-01) 2017-03-010000-00-00NoNoCurrent
42571-162-424257101624220 TABLET, FILM COATED in 1 BOTTLE (42571-162-42) 2017-03-010000-00-00NoNoCurrent
42571-162-43425710162434 in 1 BLISTER PACKHistorical
42571-162-44425710162444 BLISTER PACK in 1 CARTON (42571-162-44) / 4 TABLET, FILM COATED in 1 BLISTER PACK (42571-162-43) 4 blister pack2017-03-010000-00-00NoNoCurrent