FDA.reportPublic FDA data

amoxicillin and clavulanate potassium

Product NDC
43598-213
11-digit product format
435980213
Labeler code
43598
Product ID
43598-213_4291f971-d386-411e-8d06-95be682a3961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
NDA050725
Marketing category
NDA
Marketing start
1990-10-22
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-213-502020-01-31C16284748780-19d75b9d0-4c36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate
43598-213-512020-01-31C16284748780-19d75b9d0-4c36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate
43598-213-522020-01-31C16284748780-19d75b9d0-4c36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium. A moxicillin and Clavulanate Potassium Tablets, Powder for Oral Suspension and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-213-50amoxicillin and clavulanate potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION507
43598-213-51amoxicillin and clavulanate potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION757
43598-213-52amoxicillin and clavulanate potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-213-50ML - Milliliter43598-213b98c78ef-9b24-48f9-8f1f-bc47895f595512012-07-24
43598-213-51ML - Milliliter43598-2132741783a-d3e9-4942-a3c9-a94e62ab1c6212012-07-24
43598-213-52ML - Milliliter43598-21370acb2ca-fe9c-44f3-b950-a89253280b4912012-07-24

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 [DR. REDDY'S LABORATORIES INC]6
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-213AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]7Legacy NDC, 3 package rows20160913_58a20183-4eb6-438e-bd1e-a74f4645bb0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY58a20183-4eb6-438e-bd1e-a74f4645bb0d7
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSNcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCDcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYcd60e48c-c6ce-4b30-8f82-5d9a3e5c0f512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43598-213-504359802135050 mL in 1 BOTTLE50 mlHistorical
43598-213-514359802135175 mL in 1 BOTTLE75 mlHistorical
43598-213-5243598021352100 mL in 1 BOTTLE100 mlHistorical