FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
76420-501
11-digit product format
764200501
Labeler code
76420
Product ID
76420-501_1ad2509a-4b56-b766-e063-6294a90a3d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA065063
Marketing category
ANDA
Marketing start
2020-05-01
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
Rxcui562251, 562508, 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
76420-501-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-501-20EA - Each76420-5018f650601-1118-4e68-bebe-73fa4076054a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-501AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 1 package rows20240615_a94cfba3-27ed-46a3-81ef-e9b80187c207.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSNa94cfba3-27ed-46a3-81ef-e9b80187c2072
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNa94cfba3-27ed-46a3-81ef-e9b80187c2072
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa94cfba3-27ed-46a3-81ef-e9b80187c2072
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCDa94cfba3-27ed-46a3-81ef-e9b80187c2072
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDa94cfba3-27ed-46a3-81ef-e9b80187c2072
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa94cfba3-27ed-46a3-81ef-e9b80187c2072
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa94cfba3-27ed-46a3-81ef-e9b80187c2072
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa94cfba3-27ed-46a3-81ef-e9b80187c2072
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa94cfba3-27ed-46a3-81ef-e9b80187c2072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-501-207642005012020 TABLET, FILM COATED in 1 BOTTLE (76420-501-20) 2020-05-010000-00-00NoNoCurrent