FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
10544-931
11-digit product format
105440931
Labeler code
10544
Product ID
10544-931_31a4aaf9-1795-02e7-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA091568
Marketing category
ANDA
Marketing start
2015-05-28
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
E
Listing certified through
2017-12-31
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
10544-931-062020-01-31C16284748780-19d75b9d0-a3f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amoxicillin and clavulanate potassium tablets, USP safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium tablets, USP. Amoxicillin and Clavulanate Potassium Tablets, USP 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 t
10544-931-102020-01-31C16284748780-19d75b9d0-a3f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amoxicillin and clavulanate potassium tablets, USP safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium tablets, USP. Amoxicillin and Clavulanate Potassium Tablets, USP 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 t
10544-931-142020-01-31C16284748780-19d75b9d0-a3f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amoxicillin and clavulanate potassium tablets, USP safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium tablets, USP. Amoxicillin and Clavulanate Potassium Tablets, USP 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 t
10544-931-202020-01-31C16284748780-19d75b9d0-a3f0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amoxicillin and clavulanate potassium tablets, USP safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium tablets, USP. Amoxicillin and Clavulanate Potassium Tablets, USP 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 t

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-931-06Amoxicillin and Clavulanate Potassium6 in 1 BOTTLETABLET, FILM COATED65
10544-931-10Amoxicillin and Clavulanate Potassium10 in 1 BOTTLETABLET, FILM COATED105
10544-931-14Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED145
10544-931-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-931AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]5Legacy NDC, 4 package rows20160429_1728cab8-5c19-4f89-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN1728cab8-5c19-4f89-e054-00144ff88e885
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD1728cab8-5c19-4f89-e054-00144ff88e885
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1728cab8-5c19-4f89-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-931-06105440931066 in 1 BOTTLEHistorical
10544-931-101054409311010 in 1 BOTTLEHistorical
10544-931-141054409311414 in 1 BOTTLEHistorical
10544-931-201054409312020 in 1 BOTTLEHistorical