FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
70518-3676
11-digit product format
705183676
Labeler code
70518
Product ID
70518-3676_4f7efc1b-5047-8585-e063-6294a90a3635
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091568
Marketing category
ANDA
Marketing start
2023-03-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

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
70518-3676-0Amoxicillin and Clavulanate Potassium100 in 1 BOXTABLET, FILM COATED1008
70518-3676-1Amoxicillin and Clavulanate Potassium1 in 1 POUCHTABLET, FILM COATED18
70518-3676-2Amoxicillin and Clavulanate Potassium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED288

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN80bef3fd-4f6f-4190-8865-9ac46c8947a38
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD80bef3fd-4f6f-4190-8865-9ac46c8947a38
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY80bef3fd-4f6f-4190-8865-9ac46c8947a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3676-070518367600100 in 1 BOXHistorical
70518-3676-1705183676011 in 1 POUCHHistorical
70518-3676-27051836760228 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3676-2) 2025-06-18NoNoHistorical