FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
85766-123
11-digit product format
857660123
Labeler code
85766
Product ID
85766-123_50322015-adbe-6d1c-e063-6294a90a508f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA090227
Marketing category
ANDA
Marketing start
2010-04-21
Substance
AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM
Active strength
562.5; 437.5; 62.5 mg/1; mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], 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
AMOXICILLIN562.5 mg/1
AMOXICILLIN SODIUM437.5 mg/1
CLAVULANATE POTASSIUM62.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, 544Y3D6MYH, Q42OMW3AT8
Rxcui617995

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
85766-123-28Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL282

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617995amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral TabletPSNcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272
61799512 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral TabletSCDcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272
617995amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral TabletSYcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-123-288576601232828 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (85766-123-28) 2025-11-06NoNoHistorical