FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
82804-177
11-digit product format
828040177
Labeler code
82804
Product ID
82804-177_a5253c79-997e-40d9-919b-d2ed8c51daa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
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
82804-177-14Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET142
82804-177-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-177AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [PROFICIENT RX LP]2Current NDC, 2 package rows20250418_b0d7eb3e-706a-482b-b106-9c137be55bb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNb0d7eb3e-706a-482b-b106-9c137be55bb62
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDb0d7eb3e-706a-482b-b106-9c137be55bb62
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYb0d7eb3e-706a-482b-b106-9c137be55bb62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-177-148280401771414 TABLET in 1 BOTTLE (82804-177-14) 14 tablet2024-12-20NoNoCurrent
82804-177-208280401772020 TABLET in 1 BOTTLE (82804-177-20) 20 tablet2025-04-07NoNoCurrent