FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
63187-488
11-digit product format
631870488
Labeler code
63187
Product ID
63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16
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
2002-03-14
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
63187-488-14Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED146
63187-488-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED206
63187-488-28Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, FILM COATED286
63187-488-30Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED306
63187-488-40Amoxicillin and Clavulanate Potassium40 in 1 BOTTLETABLET, FILM COATED406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-488AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20220521_5b68b2bf-b581-4372-87be-a6394ee56961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN5b68b2bf-b581-4372-87be-a6394ee569616
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD5b68b2bf-b581-4372-87be-a6394ee569616
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY5b68b2bf-b581-4372-87be-a6394ee569616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-488-146318704881414 TABLET, FILM COATED in 1 BOTTLE (63187-488-14) 2021-09-160000-00-00NoNoCurrent
63187-488-206318704882020 TABLET, FILM COATED in 1 BOTTLE (63187-488-20) 2015-02-020000-00-00NoNoCurrent
63187-488-286318704882828 TABLET, FILM COATED in 1 BOTTLE (63187-488-28) 2015-02-020000-00-00NoNoCurrent
63187-488-306318704883030 TABLET, FILM COATED in 1 BOTTLE (63187-488-30) 2015-02-020000-00-00NoNoCurrent
63187-488-406318704884040 TABLET, FILM COATED in 1 BOTTLE (63187-488-40) 2015-02-020000-00-00NoNoCurrent