FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
72189-281
11-digit product format
721890281
Labeler code
72189
Product ID
72189-281_2c2908f5-e111-e912-e063-6294a90a01c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA065064
Marketing category
ANDA
Marketing start
2021-10-07
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500; 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
AMOXICILLIN500 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617296

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
72189-281-14AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BOTTLETABLET, FILM COATED144
72189-281-20AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-281-14EA - Each72189-28153554fac-cd9b-4d95-aea0-3831992102b412022-03-09
72189-281-20EA - Each72189-281a9066824-5f49-45a6-b55a-bfb3d35641ce12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-281AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]4Current NDC, Legacy NDC, 2 package rows20250121_cdc6d30a-754e-6672-e053-2a95a90afa7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNcdc6d30a-754e-6672-e053-2a95a90afa7f4
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDcdc6d30a-754e-6672-e053-2a95a90afa7f4
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYcdc6d30a-754e-6672-e053-2a95a90afa7f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-281-147218902811414 TABLET, FILM COATED in 1 BOTTLE (72189-281-14) 2021-10-070000-00-00NoNoCurrent
72189-281-207218902812020 TABLET, FILM COATED in 1 BOTTLE (72189-281-20) 2021-10-070000-00-00NoNoCurrent