FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
65862-534
11-digit product format
658620534
Labeler code
65862
Product ID
65862-534_4bd68235-4588-4e1a-9bac-b3d98481fd03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA201090
Marketing category
ANDA
Marketing start
2011-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400; 57 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
AMOXICILLIN400 mg/5mL
CLAVULANATE POTASSIUM57 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617423, 617430

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
65862-534-01Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10014
65862-534-50Amoxicillin and Clavulanate Potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5014
65862-534-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-534-01ML - Milliliter65862-53425276cb7-787c-4741-9f5b-33ddeaedc47c12012-07-24
65862-534-50ML - Milliliter65862-534e99c0ab1-2a63-4780-9803-587aa605b96012012-07-24
65862-534-75ML - Milliliter65862-534ead24da3-d518-40af-bc4f-3aa709091a9d12012-07-24

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
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN 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 [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-534AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 3 package rows20240620_ab1dbe70-696f-4ff9-a0c7-7406bff590ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYab1dbe70-696f-4ff9-a0c7-7406bff590ae14
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY2718248d-d948-466e-959b-1a972519f10810
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYabbebdc1-4410-76af-e053-2a95a90acb9c4
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYaad174d9-2c46-49aa-9a62-61063f405c533
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNe5bd9918-b073-c50b-e053-2a95a90aaeb72
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDe5bd9918-b073-c50b-e053-2a95a90aaeb72
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYe5bd9918-b073-c50b-e053-2a95a90aaeb72
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYe5bd9918-b073-c50b-e053-2a95a90aaeb72
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNd79a5d6c-753f-807a-e053-2995a90a79fa1
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDd79a5d6c-753f-807a-e053-2995a90a79fa1
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYd79a5d6c-753f-807a-e053-2995a90a79fa1
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY9290fcb9-7991-44b6-9045-1ed3fdfe2b281
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY52b9defd-244a-444f-96d3-b747622dc2891
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYe1013b38-446b-4faf-973d-272d90ff309a1
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYd79a5d6c-753f-807a-e053-2995a90a79fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-534-0165862053401100 mL in 1 BOTTLE (65862-534-01) 100 ml2011-12-200000-00-00NoNoCurrent
65862-534-506586205345050 mL in 1 BOTTLE (65862-534-50) 50 ml2011-12-200000-00-00NoNoCurrent
65862-534-756586205347575 mL in 1 BOTTLE (65862-534-75) 75 ml2011-12-200000-00-00NoNoCurrent