Amoxicillin and Clavulanate Potassium

Product NDC
60432-065
11-digit product format
604320065
Labeler code
60432
Product ID
60432-065_8c301cc4-5174-4fa8-80af-899c3aaf18c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA065431
Marketing category
ANDA
Marketing start
2008-11-25
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250 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
2020-12-31
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-065-00ML - Milliliter60432-065a028cd3e-38d3-4577-bba1-a3fad12aeff312012-07-24
60432-065-47ML - Milliliter60432-065e527267b-84af-4e85-9953-f07907bdb90e12012-07-24
60432-065-75ML - Milliliter60432-06592daa499-8439-4671-8ecf-95cf9de0841512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Clavulanate PotassiumACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Amoxicillin AnhydrousACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Clavulanic AcidACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
MannitolINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]6
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-065AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]13Legacy NDC20241004_25e641d0-a5de-4163-938a-ea52c4bfa48e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSNb34ef1e1-9679-4c56-8a88-bf45faf3594c2
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCDb34ef1e1-9679-4c56-8a88-bf45faf3594c2
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSYb34ef1e1-9679-4c56-8a88-bf45faf3594c2
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSYb34ef1e1-9679-4c56-8a88-bf45faf3594c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-065-0060432006500100 mL in 1 BOTTLE, PLASTIC (60432-065-00) 100 ml2008-11-250000-00-00NoNoCurrent
60432-065-4760432006547150 mL in 1 BOTTLE, PLASTIC (60432-065-47) 150 ml2008-11-250000-00-00NoNoCurrent
60432-065-756043200657575 mL in 1 BOTTLE, PLASTIC (60432-065-75) 75 ml2008-11-250000-00-00NoNoCurrent