FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
68788-8307
11-digit product format
687888307
Labeler code
68788
Product ID
68788-8307_23c2896b-d08f-4948-ac77-e15df706eeac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA050720
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 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
AMOXICILLIN875 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562508

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
68788-8307-2AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, COATED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8307-2EA - Each68788-8307aa3a08e3-8de7-4e88-a5d9-6d9b1f5bc50a12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8307AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20250205_1b8a6312-ae47-45fb-ba5e-eedbc176afa0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN1b8a6312-ae47-45fb-ba5e-eedbc176afa04
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD1b8a6312-ae47-45fb-ba5e-eedbc176afa04
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1b8a6312-ae47-45fb-ba5e-eedbc176afa04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8307-26878883070220 TABLET, COATED in 1 BOTTLE (68788-8307-2) 2022-12-200000-00-00NoNoCurrent