FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
21695-546
11-digit product format
216950546
Labeler code
21695
Product ID
21695-546_d74e93e5-11c9-434e-a60c-4a4f911dd0f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065066
Marketing category
ANDA
Marketing start
2002-06-05
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400 mg/5mL; mg/5mL
Pharmacologic classes
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-546-002019-09-24C16284748780-1934fe258-4c89-48b1-e053-8cdaa90a720aAmoxicillin and Clavulanate Potassium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-546-00Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-546-00ML - Milliliter21695-5468ed4baf5-4609-49b3-9a77-7d490d6d1f3a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
Clavulanate PotassiumACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
Clavulanic acidACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
mannitolINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
succinic acidINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-546AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 1 package rows20101123_d74e93e5-11c9-434e-a60c-4a4f911dd0f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNd74e93e5-11c9-434e-a60c-4a4f911dd0f82
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDd74e93e5-11c9-434e-a60c-4a4f911dd0f82
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYd74e93e5-11c9-434e-a60c-4a4f911dd0f82
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYd74e93e5-11c9-434e-a60c-4a4f911dd0f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-546-0021695054600100 mL in 1 BOTTLE100 mlHistorical