FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
71205-651
11-digit product format
712050651
Labeler code
71205
Product ID
71205-651_f636413f-82e5-446f-94cc-b4841bdedb33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065063
Marketing category
ANDA
Marketing start
2020-05-01
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
71205-651-10Amoxicillin and Clavulanate Potassium10 in 1 BOTTLETABLET, FILM COATED101
71205-651-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED201
71205-651-30Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED301
71205-651-60Amoxicillin and Clavulanate Potassium60 in 1 BOTTLETABLET, FILM COATED601
71205-651-90Amoxicillin and Clavulanate Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-651-20EA - Each71205-651839ca1dc-66a8-482c-b067-a48da36d25b712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-651AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 5 package rows20220430_f636413f-82e5-446f-94cc-b4841bdedb33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNf636413f-82e5-446f-94cc-b4841bdedb331
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDf636413f-82e5-446f-94cc-b4841bdedb331
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf636413f-82e5-446f-94cc-b4841bdedb331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-651-107120506511010 TABLET, FILM COATED in 1 BOTTLE (71205-651-10) 2022-04-210000-00-00NoNoCurrent
71205-651-207120506512020 TABLET, FILM COATED in 1 BOTTLE (71205-651-20) 2022-04-210000-00-00NoNoCurrent
71205-651-307120506513030 TABLET, FILM COATED in 1 BOTTLE (71205-651-30) 2022-04-210000-00-00NoNoCurrent
71205-651-607120506516060 TABLET, FILM COATED in 1 BOTTLE (71205-651-60) 2022-04-210000-00-00NoNoCurrent
71205-651-907120506519090 TABLET, FILM COATED in 1 BOTTLE (71205-651-90) 2022-04-210000-00-00NoNoCurrent