FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0093-2279
11-digit product format
000932279
Labeler code
0093
Product ID
0093-2279_aaf9ce2f-41c3-489c-b5c1-f4f553d84854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065089
Marketing category
ANDA
Marketing start
2005-01-13
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400; 57 mg/5mL; mg/5mL
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

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-2279-73Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2279-73ML - Milliliter0093-2279b415ecaa-0260-4a94-9e04-a02ad90e351f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGAAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
TRIACETININACTIVE INGREDIENTXHX3C3X673AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-2279AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA, INC.]29Current NDC, Legacy NDC, 1 package rows20240824_963e7bea-ff5d-420a-9cb2-e4aefb534b33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN963e7bea-ff5d-420a-9cb2-e4aefb534b3331
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD963e7bea-ff5d-420a-9cb2-e4aefb534b3331
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY963e7bea-ff5d-420a-9cb2-e4aefb534b3331
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY963e7bea-ff5d-420a-9cb2-e4aefb534b3331
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN57ee4d6c-94ff-4a40-98df-3e0170c382fc7
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD57ee4d6c-94ff-4a40-98df-3e0170c382fc7
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY57ee4d6c-94ff-4a40-98df-3e0170c382fc7
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY57ee4d6c-94ff-4a40-98df-3e0170c382fc7
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN5db8df09-4e06-4681-918d-29ca6b50b3ec5
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD5db8df09-4e06-4681-918d-29ca6b50b3ec5
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY5db8df09-4e06-4681-918d-29ca6b50b3ec5
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY5db8df09-4e06-4681-918d-29ca6b50b3ec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-2279-7300093227973100 mL in 1 BOTTLE (0093-2279-73) 100 ml2005-01-130000-00-00NoNoCurrent