FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-0820
11-digit product format
500900820
Labeler code
50090
Product ID
50090-0820_6dff41b3-f2fe-4f50-aef9-0b01bc06d458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091569
Marketing category
ANDA
Marketing start
2012-01-20
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
UniiQ42OMW3AT8, 804826J2HU
Rxcui562508, 617296

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
50090-0820-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED2025
50090-0820-1Amoxicillin and Clavulanate Potassium21 in 1 BOTTLETABLET, FILM COATED2125
50090-0820-2Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED3025
50090-0820-3Amoxicillin and Clavulanate Potassium15 in 1 BOTTLETABLET, FILM COATED1525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0820-0EA - Each50090-0820c4832c6f-622c-4286-9930-09610b35c91712024-06-10
50090-0820-1EA - Each50090-082094076206-5c8b-445b-b861-0ee419913d2212024-06-10
50090-0820-2EA - Each50090-0820390ebbc2-a14e-40f2-9d95-7ed42d9dbfc312024-06-10
50090-0820-3EA - Each50090-082050fb9cb3-0f5a-489d-b20e-20ea0d6f44c312024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0820AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]23Current NDC, Legacy NDC, 4 package rows20240516_af4c2ea8-73bd-429b-8392-fa20fec6fb3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYaf4c2ea8-73bd-429b-8392-fa20fec6fb3f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0820-05009008200020 TABLET, FILM COATED in 1 BOTTLE (50090-0820-0) 2014-11-280000-00-00NoNoCurrent
50090-0820-15009008200121 TABLET, FILM COATED in 1 BOTTLE (50090-0820-1) 2014-11-280000-00-00NoNoCurrent
50090-0820-25009008200230 TABLET, FILM COATED in 1 BOTTLE (50090-0820-2) 2014-11-280000-00-00NoNoCurrent
50090-0820-35009008200315 TABLET, FILM COATED in 1 BOTTLE (50090-0820-3) 2014-11-280000-00-00NoNoCurrent