FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0143-9853
11-digit product format
001439853
Labeler code
0143
Product ID
0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065373
Marketing category
ANDA
Marketing start
2009-08-03
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600; 42.9 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN600 mg/5mL
CLAVULANATE POTASSIUM42.9 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617993

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
0143-9853-16Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLESUSPENSION12514
0143-9853-24Amoxicillin and Clavulanate Potassium200 mL in 1 BOTTLESUSPENSION20014
0143-9853-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLESUSPENSION7514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9853-16ML - Milliliter0143-985353ec010b-87bd-4078-ab40-b5ad3076e2de12012-07-24
0143-9853-24ML - Milliliter0143-9853b2706ca9-6e05-443a-a0cb-b6375068e48612012-07-24
0143-9853-75ML - Milliliter0143-98531ea30c59-be86-489d-9b4a-9eb4603f153d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9853AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 3 package rows20240625_6339bcdb-060f-4558-9f42-6bf7f935e138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e15
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e15
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e15
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e15
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN6339bcdb-060f-4558-9f42-6bf7f935e13814
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD6339bcdb-060f-4558-9f42-6bf7f935e13814
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY6339bcdb-060f-4558-9f42-6bf7f935e13814
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY6339bcdb-060f-4558-9f42-6bf7f935e13814
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYfc31a5df-aa1c-4b0f-8c64-a14236df4a025
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN85f3972f-205e-4de6-b8ce-aa93cd1a0e2e4
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD85f3972f-205e-4de6-b8ce-aa93cd1a0e2e4
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY85f3972f-205e-4de6-b8ce-aa93cd1a0e2e4
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY85f3972f-205e-4de6-b8ce-aa93cd1a0e2e4
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN16915fe9-1ac9-4ebb-afc8-eeb89144f30c2
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD16915fe9-1ac9-4ebb-afc8-eeb89144f30c2
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY16915fe9-1ac9-4ebb-afc8-eeb89144f30c2
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY16915fe9-1ac9-4ebb-afc8-eeb89144f30c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9853-1600143985316125 mL in 1 BOTTLE (0143-9853-16) 125 ml2009-08-030000-00-00NoNoCurrent
0143-9853-2400143985324200 mL in 1 BOTTLE (0143-9853-24) 200 ml2009-08-030000-00-00NoNoCurrent
0143-9853-750014398537575 mL in 1 BOTTLE (0143-9853-75) 75 ml2009-08-030000-00-00NoNoCurrent