FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68788-8317
11-digit product format
687888317
Labeler code
68788
Product ID
68788-8317_95ca3695-cb4f-4ce9-8f68-a22e2d72d17c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091569
Marketing category
ANDA
Marketing start
2022-12-23
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500; 125 mg/1; mg/1
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
AMOXICILLIN500 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617296

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
68788-8317-2Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8317AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20240208_d23b6952-5e4c-4103-9fe0-a916b1e2e1b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSNd23b6952-5e4c-4103-9fe0-a916b1e2e1b95
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCDd23b6952-5e4c-4103-9fe0-a916b1e2e1b95
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd23b6952-5e4c-4103-9fe0-a916b1e2e1b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8317-26878883170220 TABLET, FILM COATED in 1 BOTTLE (68788-8317-2) 2022-12-230000-00-00NoNoCurrent