FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
65862-533
11-digit product format
658620533
Labeler code
65862
Product ID
65862-533_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
200; 28.5 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
AMOXICILLIN200 mg/5mL
CLAVULANATE POTASSIUM28.5 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
65862-533-01Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10014
65862-533-50Amoxicillin and Clavulanate Potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5014
65862-533-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-533AMOXICILLIN 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
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN77126eee-9534-4e80-9d11-ec78ec66c8267
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD77126eee-9534-4e80-9d11-ec78ec66c8267
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY77126eee-9534-4e80-9d11-ec78ec66c8267
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY77126eee-9534-4e80-9d11-ec78ec66c8267
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN30446852-9a54-4d16-ba12-56ffd01499855
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD30446852-9a54-4d16-ba12-56ffd01499855
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY30446852-9a54-4d16-ba12-56ffd01499855
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY30446852-9a54-4d16-ba12-56ffd01499855
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN88746cfa-fa0c-480e-ac60-1a9f5320745f3
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD88746cfa-fa0c-480e-ac60-1a9f5320745f3
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY88746cfa-fa0c-480e-ac60-1a9f5320745f3
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY88746cfa-fa0c-480e-ac60-1a9f5320745f3
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN30144e2e-d336-8fa3-e063-6394a90a60681
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 SuspensionPSNfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD30144e2e-d336-8fa3-e063-6394a90a60681
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 SuspensionSCDfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY30144e2e-d336-8fa3-e063-6394a90a60681
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 SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY30144e2e-d336-8fa3-e063-6394a90a60681
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 SuspensionSYfc5dc69a-3c23-49fc-b80f-1412aebc9b761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-533-0165862053301100 mL in 1 BOTTLE (65862-533-01) 100 ml2011-12-200000-00-00NoNoCurrent
65862-533-506586205335050 mL in 1 BOTTLE (65862-533-50) 50 ml2011-12-200000-00-00NoNoCurrent
65862-533-756586205337575 mL in 1 BOTTLE (65862-533-75) 75 ml2011-12-200000-00-00NoNoCurrent