FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
70518-2263
11-digit product format
705182263
Labeler code
70518
Product ID
70518-2263_4dda203b-5045-e608-e063-6294a90aa2b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204755
Marketing category
ANDA
Marketing start
2019-08-12
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
70518-2263-0AMOXICILLIN AND CLAVULANATE POTASSIUM30 in 1 BLISTER PACKTABLET, FILM COATED3021
70518-2263-1AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BLISTER PACKTABLET, FILM COATED2021
70518-2263-2AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BLISTER PACKTABLET, FILM COATED1421
70518-2263-3AMOXICILLIN AND CLAVULANATE POTASSIUM100 in 1 BOXTABLET, FILM COATED10021
70518-2263-4AMOXICILLIN AND CLAVULANATE POTASSIUM1 in 1 POUCHTABLET, FILM COATED121
70518-2263-5AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BLISTER PACKTABLET, FILM COATED2021
70518-2263-6AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BLISTER PACKTABLET, FILM COATED1421
70518-2263-7AMOXICILLIN AND CLAVULANATE POTASSIUM30 in 1 BLISTER PACKTABLET, FILM COATED3021
70518-2263-8AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2021
70518-2263-9AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2263AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 10 package rows20250210_a26f2ceb-bb9b-4813-9691-634338186860.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa26f2ceb-bb9b-4813-9691-63433818686021
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa26f2ceb-bb9b-4813-9691-63433818686021
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa26f2ceb-bb9b-4813-9691-63433818686021
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN3f9beabd-b579-460a-8ceb-789389b109f81
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD3f9beabd-b579-460a-8ceb-789389b109f81
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY3f9beabd-b579-460a-8ceb-789389b109f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2263-07051822630030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-0) 2019-08-120000-00-00NoNoCurrent
70518-2263-17051822630120 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-1) 2019-08-120000-00-00NoNoCurrent
70518-2263-27051822630214 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-2) 2019-12-120000-00-00NoNoCurrent
70518-2263-370518226303100 POUCH in 1 BOX (70518-2263-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-2263-4) 100 pouch2021-11-170000-00-00NoNoCurrent
70518-2263-4705182263041 in 1 POUCHHistorical
70518-2263-57051822630520 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-5) 2021-12-130000-00-00NoNoCurrent
70518-2263-67051822630614 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-6) 2022-09-070000-00-00NoNoCurrent
70518-2263-77051822630730 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-7) 2022-09-140000-00-00NoNoCurrent
70518-2263-87051822630820 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-8) 2023-03-14NoNoCurrent
70518-2263-97051822630914 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-9) 2023-04-04NoNoCurrent