FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
70934-039
11-digit product format
709340039
Labeler code
70934
Product ID
70934-039_d1f2ff17-8a95-f3a8-e053-2a95a90a7c04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA091568
Marketing category
ANDA
Marketing start
2017-10-23
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 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
2022-12-31
Current FDA listing
Historical FDA.report record

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
70934-039-102023-01-30C16284748780-1f386c649-a528-0266-e053-dadaa90a7c1aThese 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
70934-039-142023-01-30C16284748780-1f386c649-a528-0266-e053-dadaa90a7c1aThese 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
70934-039-912023-01-30C16284748780-1f386c649-a528-0266-e053-dadaa90a7c1aThese 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
70934-039-942023-01-30C16284748780-1f386c649-a528-0266-e053-dadaa90a7c1aThese 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
70934-039-10Amoxicillin and Clavulanate Potassium10 in 1 BOTTLE, PLASTICTABLET, FILM COATED105
70934-039-14Amoxicillin and Clavulanate Potassium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED145
70934-039-91Amoxicillin and Clavulanate Potassium20 in 1 DOSE PACKTABLET, FILM COATED205
70934-039-94Amoxicillin and Clavulanate Potassium30 in 1 DOSE PACKTABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-039-10EA - Each70934-039d4c21210-32b3-4fa3-b17c-b23a31b6eab112018-09-05
70934-039-14EA - Each70934-03973b70f95-d4a0-4c81-9e21-ed9307a55dda12018-05-09
70934-039-91EA - Each70934-03926b9c903-e6a0-41d3-b2c7-05400915e75112018-05-09
70934-039-94EA - Each70934-039d0f6f3f9-0f5e-4aeb-85c3-5c63f6aa9b2e12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-039AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]5Legacy NDC, 4 package rows20211230_61cfb334-ebad-6290-e053-2a91aa0aea0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN61cfb334-ebad-6290-e053-2a91aa0aea0d5
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD61cfb334-ebad-6290-e053-2a91aa0aea0d5
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY61cfb334-ebad-6290-e053-2a91aa0aea0d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-039-107093400391010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-039-10) 2018-06-110000-00-00NoNoCurrent
70934-039-147093400391414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-039-14) 2017-12-200000-00-00NoNoCurrent
70934-039-917093400399120 TABLET, FILM COATED in 1 DOSE PACK (70934-039-91) 2017-10-230000-00-00NoNoCurrent
70934-039-947093400399430 TABLET, FILM COATED in 1 DOSE PACK (70934-039-94) 2017-10-230000-00-00NoNoCurrent