FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68071-4967
11-digit product format
680714967
Labeler code
68071
Product ID
68071-4967_4604b05b-cda3-9410-e063-6394a90ab875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4967-22024-06-18C16284748780-1ba0f9c33-45fc-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 T ABLETS. 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 Ta
68071-4967-22023-01-30C16284748780-1ba0f9c33-45fc-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 T ABLETS. 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 Ta
68071-4967-22021-02-18C16284748780-1ba0f9c33-45fc-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 T ABLETS. 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 Ta
68071-4967-22021-01-29C16284748780-1ba0f9c33-45fc-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 T ABLETS. 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 Ta

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4967-2Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4967AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240619_8dba4e86-5f79-0bea-e053-2a95a90a9e2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN8dba4e86-5f79-0bea-e053-2a95a90a9e2d4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD8dba4e86-5f79-0bea-e053-2a95a90a9e2d4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY8dba4e86-5f79-0bea-e053-2a95a90a9e2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4967-26807149670220 TABLET in 1 BOTTLE (68071-4967-2) 20 tablet2019-07-150000-00-00NoNoCurrent