FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
65862-535
11-digit product format
658620535
Labeler code
65862
Product ID
65862-535_3d50990e-9d7e-4a23-a135-97d5612ec0bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA201091
Marketing category
ANDA
Marketing start
2011-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600; 42.9 mg/5mL; mg/5mL
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
AMOXICILLIN600 mg/5mL
CLAVULANATE POTASSIUM42.9 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617993

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
65862-535-02Amoxicillin and Clavulanate Potassium200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION20015
65862-535-13Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION12515
65862-535-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-535-02ML - Milliliter65862-535147baf52-d412-4dc9-97c5-af638eab6b2a12012-07-24
65862-535-13ML - Milliliter65862-535eca6d1cd-6ee2-4919-ac4f-59d813457c2612012-07-24
65862-535-75ML - Milliliter65862-5352fb1e45e-c1c8-4cdd-8609-24163ef0ff9012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-535AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 3 package rows20250225_5200ae31-8a79-45f9-84fc-98f8448483a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN5200ae31-8a79-45f9-84fc-98f8448483a715
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD5200ae31-8a79-45f9-84fc-98f8448483a715
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY5200ae31-8a79-45f9-84fc-98f8448483a715
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY5200ae31-8a79-45f9-84fc-98f8448483a715
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN22a387bd-92ce-4ebc-b475-20d7750a250713
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN2a376d67-0bf2-43a1-8ca3-73f90689c33913
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD22a387bd-92ce-4ebc-b475-20d7750a250713
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD2a376d67-0bf2-43a1-8ca3-73f90689c33913
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY2a376d67-0bf2-43a1-8ca3-73f90689c33913
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY22a387bd-92ce-4ebc-b475-20d7750a250713
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY2a376d67-0bf2-43a1-8ca3-73f90689c33913
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY22a387bd-92ce-4ebc-b475-20d7750a250713
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd4
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd4
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd4
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd4
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY476ea419-8d88-40f0-a329-960e5e3859c64
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNa0ff848d-230a-ab6b-e053-2a95a90a8bb83
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDa0ff848d-230a-ab6b-e053-2a95a90a8bb83
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYa0ff848d-230a-ab6b-e053-2a95a90a8bb83
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYa0ff848d-230a-ab6b-e053-2a95a90a8bb83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-535-0265862053502200 mL in 1 BOTTLE (65862-535-02) 200 ml2011-12-200000-00-00NoNoCurrent
65862-535-1365862053513125 mL in 1 BOTTLE (65862-535-13) 125 ml2011-12-200000-00-00NoNoCurrent
65862-535-756586205357575 mL in 1 BOTTLE (65862-535-75) 75 ml2011-12-200000-00-00NoNoCurrent