FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68788-8770
11-digit product format
687888770
Labeler code
68788
Product ID
68788-8770_0295f6ef-bd98-477a-a6d9-376561bb6d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065373
Marketing category
ANDA
Marketing start
2024-11-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

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
68788-8770-1Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLESUSPENSION1252
68788-8770-7Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLESUSPENSION752

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8770-1ML - Milliliter68788-8770672c0b99-3b72-4006-bec1-dfb1dc4e25d412025-02-10
68788-8770-7ML - Milliliter68788-877043f10b5d-b884-4749-b322-e0f11ca79ade12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8770AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241122_16915fe9-1ac9-4ebb-afc8-eeb89144f30c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
68788-8770-168788877001125 mL in 1 BOTTLE (68788-8770-1) 125 ml2024-11-20NoNoHistorical
68788-8770-76878887700775 mL in 1 BOTTLE (68788-8770-7) 75 ml2024-11-20NoNoHistorical