FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
52959-702
11-digit product format
529590702
Labeler code
52959
Product ID
52959-702_9404bff5-10f1-4359-8894-b6a5cb5ae198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065101
Marketing category
ANDA
Marketing start
2011-01-25
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500 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
52959-702-042019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-092019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-122019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-142019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-152019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-202019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-212019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-302019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only
52959-702-402019-11-13C16284748780-197449f38-c680-f6ea-e053-dbdaa90aa703AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg 2274 2275 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-702-04Amoxicillin and Clavulanate Potassium4 in 1 BOTTLETABLET, FILM COATED44
52959-702-09Amoxicillin and Clavulanate Potassium9 in 1 BOTTLETABLET, FILM COATED94
52959-702-12Amoxicillin and Clavulanate Potassium12 in 1 BOTTLETABLET, FILM COATED124
52959-702-14Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED144
52959-702-15Amoxicillin and Clavulanate Potassium15 in 1 BOTTLETABLET, FILM COATED154
52959-702-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED204
52959-702-21Amoxicillin and Clavulanate Potassium21 in 1 BOTTLETABLET, FILM COATED214
52959-702-30Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED304
52959-702-40Amoxicillin and Clavulanate Potassium40 in 1 BOTTLETABLET, FILM COATED404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-702-04EA - Each52959-70203403b97-1561-454f-8389-d7bba9652d4912012-07-24
52959-702-09EA - Each52959-7029282241f-5f60-4a3b-b9f4-bc66bdd13b1c12012-07-24
52959-702-12EA - Each52959-70224275f30-6ece-4ba7-9c47-337e2da1d52e12012-07-24
52959-702-14EA - Each52959-702c9b7f3ff-6082-442a-933f-52c3bbbd914b12012-07-24
52959-702-15EA - Each52959-702ce985e25-dbe4-4a1d-bfca-2b5b4aa3981d12012-07-24
52959-702-20EA - Each52959-702fcec2738-7739-4bf2-9a79-df7c661b676812012-07-24
52959-702-21EA - Each52959-702f9a06f05-73d7-44f8-98fb-10608084cdb812012-07-24
52959-702-30EA - Each52959-7025033fec8-0340-4b47-8a32-a3f3c23b9af212012-07-24
52959-702-40EA - Each52959-702a434fa52-cbe6-49c8-b93e-ee730cdc2fc712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]4
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]4
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-702AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 9 package rows20111227_22b16383-9ce3-45e7-80c3-db332f59abbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN22b16383-9ce3-45e7-80c3-db332f59abbf4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN22b16383-9ce3-45e7-80c3-db332f59abbf4
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD22b16383-9ce3-45e7-80c3-db332f59abbf4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD22b16383-9ce3-45e7-80c3-db332f59abbf4
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY22b16383-9ce3-45e7-80c3-db332f59abbf4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY22b16383-9ce3-45e7-80c3-db332f59abbf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-702-04529590702044 in 1 BOTTLEHistorical
52959-702-09529590702099 in 1 BOTTLEHistorical
52959-702-125295907021212 in 1 BOTTLEHistorical
52959-702-145295907021414 in 1 BOTTLEHistorical
52959-702-155295907021515 in 1 BOTTLEHistorical
52959-702-205295907022020 in 1 BOTTLEHistorical
52959-702-215295907022121 in 1 BOTTLEHistorical
52959-702-305295907023030 in 1 BOTTLEHistorical
52959-702-405295907024040 in 1 BOTTLEHistorical