FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68788-8318
11-digit product format
687888318
Labeler code
68788
Product ID
68788-8318_2c966f10-3845-4fa9-aa1f-c56e7a671252
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201090
Marketing category
ANDA
Marketing start
2022-12-23
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400; 57 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
AMOXICILLIN400 mg/5mL
CLAVULANATE POTASSIUM57 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617430

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
68788-8318-1Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8318-1ML - Milliliter68788-8318000eabf6-50e5-4aa8-97df-8c4d633c394a12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8318AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20250126_618953a3-0256-42ce-9155-d35325f017aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY618953a3-0256-42ce-9155-d35325f017aa5
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY618953a3-0256-42ce-9155-d35325f017aa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8318-168788831801100 mL in 1 BOTTLE (68788-8318-1) 100 ml2022-12-230000-00-00NoNoCurrent