FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
65862-502
11-digit product format
658620502
Labeler code
65862
Product ID
65862-502_2b91e9f8-c77e-4330-8fc1-e574758f0db6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA091569
Marketing category
ANDA
Marketing start
2012-01-20
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
2026-12-31

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
65862-502-05Amoxicillin and Clavulanate Potassium500 in 1 BOTTLETABLET, FILM COATED50023
65862-502-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED2023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-502-20EA - Each65862-50231730386-a236-482f-9897-e88bf33ac5a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-502AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]21Current NDC, Legacy NDC, 2 package rows20240821_ffb158a1-83ba-4100-9221-175aa986dc3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSNffb158a1-83ba-4100-9221-175aa986dc3e23
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNffb158a1-83ba-4100-9221-175aa986dc3e23
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNffb158a1-83ba-4100-9221-175aa986dc3e23
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCDffb158a1-83ba-4100-9221-175aa986dc3e23
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDffb158a1-83ba-4100-9221-175aa986dc3e23
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDffb158a1-83ba-4100-9221-175aa986dc3e23
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYffb158a1-83ba-4100-9221-175aa986dc3e23
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYffb158a1-83ba-4100-9221-175aa986dc3e23
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYffb158a1-83ba-4100-9221-175aa986dc3e23
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN6441558e-2d6c-b37d-e053-2991aa0adf505
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNd23b6952-5e4c-4103-9fe0-a916b1e2e1b95
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDd23b6952-5e4c-4103-9fe0-a916b1e2e1b95
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD6441558e-2d6c-b37d-e053-2991aa0adf505
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6441558e-2d6c-b37d-e053-2991aa0adf505
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd23b6952-5e4c-4103-9fe0-a916b1e2e1b95
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN46921419-9fae-4f51-b1b2-dc2e1ab04e8e4
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD46921419-9fae-4f51-b1b2-dc2e1ab04e8e4
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY46921419-9fae-4f51-b1b2-dc2e1ab04e8e4
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNb509d0eb-fe01-4902-89ae-a0dc7f7c7f933
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN94b7c1bb-c024-4dc6-86d4-18a17a3eafcb3
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN94b7c1bb-c024-4dc6-86d4-18a17a3eafcb3
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD94b7c1bb-c024-4dc6-86d4-18a17a3eafcb3
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDb509d0eb-fe01-4902-89ae-a0dc7f7c7f933
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD94b7c1bb-c024-4dc6-86d4-18a17a3eafcb3
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY94b7c1bb-c024-4dc6-86d4-18a17a3eafcb3
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYb509d0eb-fe01-4902-89ae-a0dc7f7c7f933
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY94b7c1bb-c024-4dc6-86d4-18a17a3eafcb3
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNef2c7783-e419-288f-e053-2a95a90a628a2
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNf433611c-db72-af7f-e053-2995a90a4a702
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDef2c7783-e419-288f-e053-2a95a90a628a2
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDf433611c-db72-af7f-e053-2995a90a4a702
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYef2c7783-e419-288f-e053-2a95a90a628a2
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf433611c-db72-af7f-e053-2995a90a4a702
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN48356a07-60b9-c844-e063-6394a90afafa1
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD48356a07-60b9-c844-e063-6394a90afafa1
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY48356a07-60b9-c844-e063-6394a90afafa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-502-0565862050205500 TABLET, FILM COATED in 1 BOTTLE (65862-502-05) 2012-01-200000-00-00NoNoCurrent
65862-502-206586205022020 TABLET, FILM COATED in 1 BOTTLE (65862-502-20) 2012-01-200000-00-00NoNoCurrent