FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-1857
11-digit product format
500901857
Labeler code
50090
Product ID
50090-1857_19b426f7-156d-48ac-8691-bbf672c5c0b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-1857-0Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION12517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1857-0ML - Milliliter50090-18578affbcd3-ced4-419e-ba6c-6172802ef7de12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1857AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 1 package rows20240516_ccb8bfb1-1303-4c2d-9106-78684e6b859f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYccb8bfb1-1303-4c2d-9106-78684e6b859f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1857-050090185700125 mL in 1 BOTTLE (50090-1857-0) 125 ml2015-06-03NoNoHistorical