FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50436-3129
11-digit product format
504363129
Labeler code
50436
Product ID
50436-3129_66e466b2-fce8-4158-8d30-ab6ebeb951ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065096
Marketing category
ANDA
Marketing start
2002-10-31
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 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
2019-12-31
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
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
50436-3129-12020-01-31C16284748780-19d75b9cf-fdd6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable). AMOXICILLIN AND CLAVULANAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3129-1Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3129-1EA - Each50436-3129affb2e83-61ec-488f-a070-36078b86091b12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3129AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20170307_3580641d-64c7-4cca-b5fd-ad0c82ffe8c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN3580641d-64c7-4cca-b5fd-ad0c82ffe8c74
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD3580641d-64c7-4cca-b5fd-ad0c82ffe8c74
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY3580641d-64c7-4cca-b5fd-ad0c82ffe8c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3129-15043631290120 in 1 BOTTLEHistorical