FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0781-1874
11-digit product format
007811874
Labeler code
0781
Product ID
0781-1874_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065189
Marketing category
ANDA
Marketing start
2005-08-23
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250; 125 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562251, 562508, 617296, 617423, 617430

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1874-31Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1874-31EA - Each0781-1874f4cd81b5-10e7-438c-bd38-baadb26f99b812012-07-24

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 [SANDOZ INC]16
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
BANANAINACTIVE INGREDIENT4AJZ4765R9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CHERRYINACTIVE INGREDIENTBUC5I9595WAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ 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 [SANDOZ INC]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ 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 [SANDOZ INC]16
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ INC]16
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1874AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]26Current NDC, Legacy NDC, 1 package rows20241128_7cba82f0-9886-46e9-8dbd-43a448aade29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7cba82f0-9886-46e9-8dbd-43a448aade2927
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7cba82f0-9886-46e9-8dbd-43a448aade2927
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY7cba82f0-9886-46e9-8dbd-43a448aade2927
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN7f725b99-c327-4ba4-a3cb-356f344be7781
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSNa4c9694c-f539-470e-bfe3-8723fa1c343d1
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD7f725b99-c327-4ba4-a3cb-356f344be7781
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCDa4c9694c-f539-470e-bfe3-8723fa1c343d1
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7f725b99-c327-4ba4-a3cb-356f344be7781
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa4c9694c-f539-470e-bfe3-8723fa1c343d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1874-310078118743130 TABLET, FILM COATED in 1 BOTTLE (0781-1874-31) 2005-08-230000-00-00NoNoCurrent