FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
70518-4148
11-digit product format
705184148
Labeler code
70518
Product ID
70518-4148_3fb5a186-878e-1c7c-e063-6394a90a8214
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203824
Marketing category
ANDA
Marketing start
2024-07-25
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
70518-4148-0Amoxicillin and Clavulanate Potassium100 in 1 BOXTABLET1006
70518-4148-1Amoxicillin and Clavulanate Potassium1 in 1 POUCHTABLET16
70518-4148-2Amoxicillin and Clavulanate Potassium20 in 1 BLISTER PACKTABLET206
70518-4148-3Amoxicillin and Clavulanate Potassium30 in 1 BLISTER PACKTABLET306
70518-4148-4Amoxicillin and Clavulanate Potassium14 in 1 BLISTER PACKTABLET146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4148AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [REMEDYREPACK INC.]5Current NDC, 5 package rows20250508_e5b0770d-1301-498e-a4ed-41874d7bf225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNe5b0770d-1301-498e-a4ed-41874d7bf2256
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDe5b0770d-1301-498e-a4ed-41874d7bf2256
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYe5b0770d-1301-498e-a4ed-41874d7bf2256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4148-070518414800100 POUCH in 1 BOX (70518-4148-0) / 1 TABLET in 1 POUCH (70518-4148-1) 100 pouch2024-07-25NoNoCurrent
70518-4148-1705184148011 in 1 POUCHHistorical
70518-4148-27051841480220 TABLET in 1 BLISTER PACK (70518-4148-2) 20 tablet2025-01-28NoNoCurrent
70518-4148-37051841480330 TABLET in 1 BLISTER PACK (70518-4148-3) 30 tablet2025-02-18NoNoCurrent
70518-4148-47051841480414 TABLET in 1 BLISTER PACK (70518-4148-4) 14 tablet2025-05-06NoNoCurrent