FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
80425-0180
11-digit product format
804250180
Labeler code
80425
Product ID
80425-0180_2d324dc5-6376-be6b-e063-6394a90a82dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA204755
Marketing category
ANDA
Marketing start
2017-03-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 125 mg/1; mg/1
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
AMOXICILLIN875 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562508

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
80425-0180-1Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED206
80425-0180-2Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED306
80425-0180-3Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0180-1EA - Each80425-0180444739e5-da19-41e1-8824-9f7dd13f80d412023-03-13
80425-0180-2EA - Each80425-0180d04fe114-f486-4525-b5ac-9899de674fcf12023-03-13
80425-0180-3EA - Each80425-0180bfa4e2cd-b009-4e92-9271-46e708d5316a12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0180AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20250204_d294e4a2-8ce7-418d-e053-2a95a90ab10b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNd294e4a2-8ce7-418d-e053-2a95a90ab10b6
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDd294e4a2-8ce7-418d-e053-2a95a90ab10b6
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd294e4a2-8ce7-418d-e053-2a95a90ab10b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0180-18042501800120 TABLET, FILM COATED in 1 BOTTLE (80425-0180-1) 2017-03-010000-00-00NoNoCurrent
80425-0180-28042501800230 TABLET, FILM COATED in 1 BOTTLE (80425-0180-2) 2017-03-010000-00-00NoNoCurrent
80425-0180-38042501800314 TABLET, FILM COATED in 1 BOTTLE (80425-0180-3) 2025-02-02NoNoCurrent