AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
61919-202
11-digit product format
619190202
Labeler code
61919
Product ID
61919-202_bb5e2188-2ddd-46cb-ad72-ea2448c1dfe6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA091568
Marketing category
ANDA
Marketing start
2015-01-01
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
61919-202-202020-01-31C16284748780-19d75b9d0-260e-f424-e053-dadaa90a57ceAMOXICILLIN AND CLAVULANATE POTASSIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-202-20AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-202-20EA - Each61919-2020e22515f-1ab4-4cf0-9cbb-32e5d1df4b7912016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-202AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20151112_70c5dcb1-ebad-4297-a3bd-88ab5a70d86c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN70c5dcb1-ebad-4297-a3bd-88ab5a70d86c1
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD70c5dcb1-ebad-4297-a3bd-88ab5a70d86c1
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY70c5dcb1-ebad-4297-a3bd-88ab5a70d86c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-202-206191902022020 in 1 BOTTLEHistorical