FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
81964-220
11-digit product format
819640220
Labeler code
81964
Product ID
81964-220_45c6020c-fd42-d920-e063-6294a90a67e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
USAntibiotics, LLC
Application
NDA050785
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-12-15
Substance
AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM
Active strength
562.5; 437.5; 62.5 mg/1; mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], 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
AMOXICILLIN562.5 mg/1
AMOXICILLIN SODIUM437.5 mg/1
CLAVULANATE POTASSIUM62.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, 544Y3D6MYH, Q42OMW3AT8
Rxcui617995

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
81964-220-28Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE281
81964-220-40Amoxicillin and Clavulanate Potassium40 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81964-220-28EA - Each81964-220210551a0-355e-45ff-9119-c1191321167c12026-02-05
81964-220-40EA - Each81964-220aeb365e3-fb08-4a6f-bcb3-ce1ed9dab81412026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617995amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral TabletPSN45c60b69-1b65-01ed-e063-6294a90a57be1
61799512 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral TabletSCD45c60b69-1b65-01ed-e063-6294a90a57be1
617995amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral TabletSY45c60b69-1b65-01ed-e063-6294a90a57be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81964-220-288196402202828 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28) 2025-12-15NoNoCurrent
81964-220-408196402204040 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40) 2025-12-15NoNoCurrent