FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-0928
11-digit product format
500900928
Labeler code
50090
Product ID
50090-0928_26c0009a-da21-48b0-a02a-2161e335a2c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065191
Marketing category
ANDA
Marketing start
2007-12-01
Substance
AMOXICILLIN; CLAVULANIC ACID
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL
CLAVULANIC ACID57 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, 23521W1S24
Rxcui617430

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0928-02023-02-07C16284748780-1f386c649-a4eb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION . AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION Initial U.S. Approval: 1984 Rx Only
50090-0928-02023-01-30C16284748780-1f386c649-a4eb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION . AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION Initial U.S. Approval: 1984 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0928-0Amoxicillin and Clavulanate Potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0928-0ML - Milliliter50090-09285c22a2aa-1982-4add-9e38-f6566d82471212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0928AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20240113_483f6fca-e04e-4086-aa44-a361322b811d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN483f6fca-e04e-4086-aa44-a361322b811d11
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD483f6fca-e04e-4086-aa44-a361322b811d11
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY483f6fca-e04e-4086-aa44-a361322b811d11
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY483f6fca-e04e-4086-aa44-a361322b811d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0928-05009009280050 mL in 1 BOTTLE (50090-0928-0) 50 ml2014-11-280000-00-00NoNoCurrent