FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
59651-025
11-digit product format
596510025
Labeler code
59651
Product ID
59651-025_8c4f5611-f65b-42c2-8412-e616f149ee90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209371
Marketing category
ANDA
Marketing start
2019-04-19
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
125; 31.25 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
AMOXICILLIN125 mg/5mL
CLAVULANATE POTASSIUM31.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617302, 617322

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
59651-025-01Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007
59651-025-55Amoxicillin and Clavulanate Potassium150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1507
59651-025-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-025AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 package rows20240601_3ae0c95f-7ffa-4317-9fea-4d07b86bee72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617302amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral SuspensionPSN3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSN3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617302amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral SuspensionSCD3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCD3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617302amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617302amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSY3ae0c95f-7ffa-4317-9fea-4d07b86bee727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-025-0159651002501100 mL in 1 BOTTLE (59651-025-01) 100 ml2019-04-190000-00-00NoNoCurrent
59651-025-5559651002555150 mL in 1 BOTTLE (59651-025-55) 150 ml2019-04-190000-00-00NoNoCurrent
59651-025-755965100257575 mL in 1 BOTTLE (59651-025-75) 75 ml2019-04-190000-00-00NoNoCurrent