FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-1809
11-digit product format
500901809
Labeler code
50090
Product ID
50090-1809_d3ac1741-765a-4ffa-9a0b-b06a633ec88f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091568
Marketing category
ANDA
Marketing start
2012-01-20
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
50090-1809-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED207
50090-1809-1Amoxicillin and Clavulanate Potassium10 in 1 BOTTLETABLET, FILM COATED107
50090-1809-2Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED147
50090-1809-3Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, FILM COATED287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1809-0EA - Each50090-18097280386e-c3f4-4bdf-b130-0018c737487812026-04-20
50090-1809-1EA - Each50090-1809c68d6a61-ac19-4a57-b023-b0c4cabf630412026-04-20
50090-1809-2EA - Each50090-180998391aa4-c425-4936-9836-db1c1ded984712026-04-20
50090-1809-3EA - Each50090-1809f861d6bc-508a-4dcb-a080-e7aefa749e6b12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN924a9ef6-5e3d-4e78-ae97-ae090f6613c07
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD924a9ef6-5e3d-4e78-ae97-ae090f6613c07
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY924a9ef6-5e3d-4e78-ae97-ae090f6613c07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1809-05009018090020 TABLET, FILM COATED in 1 BOTTLE (50090-1809-0) 2015-05-07NoNoHistorical
50090-1809-15009018090110 TABLET, FILM COATED in 1 BOTTLE (50090-1809-1) 2025-09-18NoNoHistorical
50090-1809-25009018090214 TABLET, FILM COATED in 1 BOTTLE (50090-1809-2) 2015-05-07NoNoHistorical
50090-1809-35009018090328 TABLET, FILM COATED in 1 BOTTLE (50090-1809-3) 2015-05-07NoNoHistorical