FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
16714-477
11-digit product format
167140477
Labeler code
16714
Product ID
16714-477_3327c23e-bb50-425b-989d-eea2568c99f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA065064
Marketing category
ANDA
Marketing start
2015-11-01
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ42OMW3AT8, 804826J2HU
Rxcui562251, 562508, 617296

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-477-01Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED2018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-477-01EA - Each16714-477f80739f8-148c-4b48-96df-80c9edf8ab1d12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-477AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHSTAR RXLLC]17Current NDC, Legacy NDC, 1 package rows20240511_d6bff811-a6ea-4e4e-a4eb-b34b966cdb40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSNd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCDd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd6bff811-a6ea-4e4e-a4eb-b34b966cdb4018
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSNa94cfba3-27ed-46a3-81ef-e9b80187c2072
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNa94cfba3-27ed-46a3-81ef-e9b80187c2072
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa94cfba3-27ed-46a3-81ef-e9b80187c2072
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCDa94cfba3-27ed-46a3-81ef-e9b80187c2072
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDa94cfba3-27ed-46a3-81ef-e9b80187c2072
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa94cfba3-27ed-46a3-81ef-e9b80187c2072
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa94cfba3-27ed-46a3-81ef-e9b80187c2072
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa94cfba3-27ed-46a3-81ef-e9b80187c2072
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa94cfba3-27ed-46a3-81ef-e9b80187c2072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-477-011671404770120 TABLET, FILM COATED in 1 BOTTLE (16714-477-01) 2015-11-010000-00-00NoNoCurrent