FDA.reportPublic FDA data

NDC 63304-979-01 - Amoxicillin and clavulanate potassium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63304-979
Requested NDC
63304-979-01
Package NDCs from labels
63304-979-03, 63304-979-01, 63304-979-04
Manufacturer
Ranbaxy Pharmaceuticals Inc.
Effective date
2008-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin and clavulanate potassium - Ranbaxy Pharmaceuticals Inc.Ranbaxy Pharmaceuticals Inc.2008-05-01HUMAN PRESCRIPTION DRUG LABELING
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-979-01Amoxicillin and clavulanate potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION751
63304-979-03Amoxicillin and clavulanate potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION501
63304-979-04Amoxicillin and clavulanate potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-979AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]13 package rows20080602_b897c800-24a2-4e76-8668-498c5515c3d0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-979-01ML - Milliliter63304-979f3afe026-6bcd-4b2c-a8e1-72f546d6f07212013-02-13
63304-979-03ML - Milliliter63304-97917af81a3-924c-4fe6-9550-8977b064f0aa12013-02-13
63304-979-04ML - Milliliter63304-979caadf23d-ef90-47eb-ab56-47fcbccf82eb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Clavulanate potassiumACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Clavulanic acidACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
AspartameINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Colloidal silicon dioxideINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
FD&C red No. 40 aluminum lakeINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Flavor strawberryINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Flavor strawberry guaranaINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
GlycineINACTIVE INGREDIENTTE7660XO1CAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
MannitolINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Mint cream flavorINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Monosodium citrateINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Orange cream flavorINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
PovidoneINACTIVE INGREDIENTFZ989GH94EAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Sodium citrate( as dihydrate)INACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Sodium starch glycolateINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Tropical blend flavorINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Xanthan gumINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2718248d-d948-466e-959b-1a972519f1082024-05-14Warnings, Adverse reactionsExact identifier
rxcui: 617430
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions61f9224b-a91b-4154-a7f3-22c14601230f2023-10-31Warnings, Adverse reactionsExact identifier
rxcui: 617423
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions029a49f2-2132-4160-a0d6-2d108a456a222023-03-02Warnings, Adverse reactionsExact identifier
rxcui: 617430
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP5db8df09-4e06-4681-918d-29ca6b50b3ec2022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 617430
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP4655e0ea-f7d5-4f7c-bf7b-266337bc05b82019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 617430
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP1f252ad3-373c-4a6d-96e7-53ba820d201b2019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 617430
21209BCF-E831-B3D6-7F05-992BFCDE3889b897c800-24a2-4e76-8668-498c5515c3d02008-05-01Warnings, Adverse reactionsExact identifier
spl id: 21209BCF-E831-B3D6-7F05-992BFCDE3889
spl set id: b897c800-24a2-4e76-8668-498c5515c3d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.