FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
72789-147
11-digit product format
727890147
Labeler code
72789
Product ID
72789-147_4af780a9-9cb0-97f0-e063-6294a90a61c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
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
72789-147-03Amoxicillin and Clavulanate Potassium3 in 1 BOTTLE, PLASTICTABLET317
72789-147-04Amoxicillin and Clavulanate Potassium4 in 1 BOTTLE, PLASTICTABLET417
72789-147-10Amoxicillin and Clavulanate Potassium10 in 1 BOTTLE, PLASTICTABLET1017
72789-147-14Amoxicillin and Clavulanate Potassium14 in 1 BOTTLE, PLASTICTABLET1417
72789-147-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLE, PLASTICTABLET2017
72789-147-28Amoxicillin and Clavulanate Potassium28 in 1 BOTTLE, PLASTICTABLET2817
72789-147-30Amoxicillin and Clavulanate Potassium30 in 1 BOTTLE, PLASTICTABLET3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-147AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 7 package rows20250207_f229e8b4-7045-4c0d-9214-890c0bda3c2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNf229e8b4-7045-4c0d-9214-890c0bda3c2a17
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDf229e8b4-7045-4c0d-9214-890c0bda3c2a17
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf229e8b4-7045-4c0d-9214-890c0bda3c2a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-147-03727890147033 TABLET in 1 BOTTLE, PLASTIC (72789-147-03) 3 tablet2020-05-150000-00-00NoNoCurrent
72789-147-04727890147044 TABLET in 1 BOTTLE, PLASTIC (72789-147-04) 4 tablet2020-11-110000-00-00NoNoCurrent
72789-147-107278901471010 TABLET in 1 BOTTLE, PLASTIC (72789-147-10) 10 tablet2020-12-300000-00-00NoNoCurrent
72789-147-147278901471414 TABLET in 1 BOTTLE, PLASTIC (72789-147-14) 14 tablet2020-11-170000-00-00NoNoCurrent
72789-147-207278901472020 TABLET in 1 BOTTLE, PLASTIC (72789-147-20) 20 tablet2020-11-110000-00-00NoNoCurrent
72789-147-287278901472828 TABLET in 1 BOTTLE, PLASTIC (72789-147-28) 28 tablet2021-04-290000-00-00NoNoCurrent
72789-147-307278901473030 TABLET in 1 BOTTLE, PLASTIC (72789-147-30) 30 tablet2020-11-110000-00-00NoNoCurrent