FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0781-6139
11-digit product format
007816139
Labeler code
0781
Product ID
0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065358
Marketing category
ANDA
Marketing start
2007-08-13
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
0781-6139-48Amoxicillin and Clavulanate Potassium200 mL in 1 BOTTLE, DISPENSINGSUSPENSION20015
0781-6139-54Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLE, DISPENSINGSUSPENSION12515
0781-6139-57Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLE, DISPENSINGSUSPENSION7515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6139-48ML - Milliliter0781-6139958f4fed-7ccd-4c99-820d-bb5f5acda6f612012-07-24
0781-6139-54ML - Milliliter0781-61390a9c61af-f2ea-4910-8330-9431ba07c2fe12012-07-24
0781-6139-57ML - Milliliter0781-6139b05caa56-c92b-418c-b607-20dfb9ab272512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
CARAMELINACTIVE INGREDIENTT9D99G2B1RAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]8
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6139AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]15Current NDC, Legacy NDC, 3 package rows20250411_99b7f40a-06f9-4b97-8eee-8e61e5106aad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN99b7f40a-06f9-4b97-8eee-8e61e5106aad15
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD99b7f40a-06f9-4b97-8eee-8e61e5106aad15
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY99b7f40a-06f9-4b97-8eee-8e61e5106aad15
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY99b7f40a-06f9-4b97-8eee-8e61e5106aad15
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN720ee5cf-1962-423b-ac81-6dd4f02b92065
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD720ee5cf-1962-423b-ac81-6dd4f02b92065
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY720ee5cf-1962-423b-ac81-6dd4f02b92065
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY720ee5cf-1962-423b-ac81-6dd4f02b92065
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNb58ec5f9-0715-4562-9aeb-915329a4eef82
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNbe64cd87-af1b-4beb-957f-963b61fd95bf2
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN474c822b-dc3d-4a55-8159-2b4b799d535b2
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD474c822b-dc3d-4a55-8159-2b4b799d535b2
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDbe64cd87-af1b-4beb-957f-963b61fd95bf2
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDb58ec5f9-0715-4562-9aeb-915329a4eef82
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYbe64cd87-af1b-4beb-957f-963b61fd95bf2
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYb58ec5f9-0715-4562-9aeb-915329a4eef82
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY474c822b-dc3d-4a55-8159-2b4b799d535b2
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYb58ec5f9-0715-4562-9aeb-915329a4eef82
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYbe64cd87-af1b-4beb-957f-963b61fd95bf2
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY474c822b-dc3d-4a55-8159-2b4b799d535b2
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN9f18d271-7cd8-4a4e-8087-6f11eddf01071
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD9f18d271-7cd8-4a4e-8087-6f11eddf01071
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY9f18d271-7cd8-4a4e-8087-6f11eddf01071
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY9f18d271-7cd8-4a4e-8087-6f11eddf01071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6139-4800781613948200 mL in 1 BOTTLE, DISPENSING (0781-6139-48) 200 ml2007-08-130000-00-00NoNoCurrent
0781-6139-5400781613954125 mL in 1 BOTTLE, DISPENSING (0781-6139-54) 125 ml2007-08-130000-00-00NoNoCurrent
0781-6139-570078161395775 mL in 1 BOTTLE, DISPENSING (0781-6139-57) 75 ml2007-08-130000-00-00NoNoCurrent