FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68071-4586
11-digit product format
680714586
Labeler code
68071
Product ID
68071-4586_49786854-db25-30be-e063-6294a90ae363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091568
Marketing category
ANDA
Marketing start
2012-01-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4586-32021-02-22C16284748780-1ba0f9c33-1b5f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tab
68071-4586-42021-02-22C16284748780-1ba0f9c33-1b5f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tab
68071-4586-32021-01-29C16284748780-1ba0f9c33-1b5f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tab
68071-4586-42021-01-29C16284748780-1ba0f9c33-1b5f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4586-3Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED308
68071-4586-4Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED148
68071-4586-6Amoxicillin and Clavulanate Potassium60 in 1 BOTTLETABLET, FILM COATED608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4586AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20240614_776da91b-0626-1090-e053-2a91aa0a40f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN776da91b-0626-1090-e053-2a91aa0a40f08
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD776da91b-0626-1090-e053-2a91aa0a40f08
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY776da91b-0626-1090-e053-2a91aa0a40f08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4586-36807145860330 TABLET, FILM COATED in 1 BOTTLE (68071-4586-3) 2018-10-040000-00-00NoNoCurrent
68071-4586-46807145860414 TABLET, FILM COATED in 1 BOTTLE (68071-4586-4) 2018-10-040000-00-00NoNoCurrent
68071-4586-66807145860660 TABLET, FILM COATED in 1 BOTTLE (68071-4586-6) 2023-09-22NoNoHistorical