FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0781-1943
11-digit product format
007811943
Labeler code
0781
Product ID
0781-1943_047eb353-1ca4-419b-947c-4d418f87c22a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA090227
Marketing category
ANDA
Marketing start
2010-04-21
Substance
AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM
Active strength
562.5; 437.5; 62.5 mg/1; mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], 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
AMOXICILLIN562.5 mg/1
AMOXICILLIN SODIUM437.5 mg/1
CLAVULANATE POTASSIUM62.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, 544Y3D6MYH, Q42OMW3AT8
Rxcui617995

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
0781-1943-39Amoxicillin and Clavulanate Potassium40 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL4027
0781-1943-82Amoxicillin and Clavulanate Potassium28 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL2827

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1943-39EA - Each0781-1943e931b958-2f91-4a8a-93e6-7e9797ee2f4912012-07-24
0781-1943-82EA - Each0781-19436c3fa966-8d3c-41cf-8cf8-10935e6880bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
AMOXICILLIN SODIUMACTIVE INGREDIENT544Y3D6MYHAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1943AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, MULTILAYER, EXTENDED RELEASE [SANDOZ INC]26Current NDC, Legacy NDC, 2 package rows20250413_e41387c8-2c74-4990-831f-64dc921ee138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617995amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral TabletPSNe41387c8-2c74-4990-831f-64dc921ee13827
61799512 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral TabletSCDe41387c8-2c74-4990-831f-64dc921ee13827
617995amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral TabletSYe41387c8-2c74-4990-831f-64dc921ee13827
617995amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral TabletPSNcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272
61799512 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral TabletSCDcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272
617995amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral TabletSYcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-1943-390078119433940 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) 2010-04-210000-00-00NoNoCurrent
0781-1943-820078119438228 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82) 2010-04-210000-00-00NoNoCurrent