FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-3179
11-digit product format
500903179
Labeler code
50090
Product ID
50090-3179_2694cd89-604e-4636-b516-d4569d1e4c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
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
2027-12-31
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
Rxcui562508

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
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
50090-3179-02023-02-07C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-12023-02-07C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-22023-02-07C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-32023-02-07C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-52023-02-07C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-02023-01-30C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-12023-01-30C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-22023-01-30C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-32023-01-30C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-3179-52023-01-30C16284748780-1f386c64a-2e69-0266-e053-dadaa90a7c1aThese 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 T ABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3179-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET2019
50090-3179-1Amoxicillin and Clavulanate Potassium10 in 1 BOTTLETABLET1019
50090-3179-2Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET1419
50090-3179-3Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET2819
50090-3179-5Amoxicillin and Clavulanate Potassium1 in 1 BOTTLETABLET119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3179AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 5 package rows20250406_a3d1c0bb-94f3-4cfb-a4c6-233cf7e519a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3179-05009031790020 TABLET in 1 BOTTLE (50090-3179-0) 20 tablet2017-10-160000-00-00NoNoCurrent
50090-3179-15009031790110 TABLET in 1 BOTTLE (50090-3179-1) 10 tablet2017-12-220000-00-00NoNoCurrent
50090-3179-25009031790214 TABLET in 1 BOTTLE (50090-3179-2) 14 tablet2017-11-010000-00-00NoNoCurrent
50090-3179-35009031790328 TABLET in 1 BOTTLE (50090-3179-3) 28 tablet2018-03-290000-00-00NoNoCurrent
50090-3179-5500903179051 TABLET in 1 BOTTLE (50090-3179-5) 1 tablet2018-03-130000-00-00NoNoCurrent