FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
82868-002
11-digit product format
828680002
Labeler code
82868
Product ID
82868-002_483362cb-ea0d-7188-e063-6394a90abe59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204755
Marketing category
ANDA
Marketing start
2023-09-26
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
82868-002-10AMOXICILLIN AND CLAVULANATE POTASSIUM10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
82868-002-14AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BOTTLE, PLASTICTABLET, FILM COATED143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-002AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240630_1069b873-9bf9-cb22-e063-6394a90a4feb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN1069b873-9bf9-cb22-e063-6394a90a4feb3
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD1069b873-9bf9-cb22-e063-6394a90a4feb3
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1069b873-9bf9-cb22-e063-6394a90a4feb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82868-002-108286800021010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-10) 2023-09-26NoNoHistorical
82868-002-148286800021414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-14) 2024-06-21NoNoHistorical