FDA.reportPublic FDA data

AUGMENTIN ES-600

Product NDC
81964-003
11-digit product format
819640003
Labeler code
81964
Product ID
81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
USAntibiotics, LLC
Application
NDA050755
Marketing category
NDA
Marketing start
2022-07-15
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600; 42.9 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AUGMENTIN ES-600
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN600 mg/5mL
CLAVULANATE POTASSIUM42.9 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617993, 618028

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
81964-003-51AUGMENTIN ES-60075 mL in 1 BOTTLEFOR SUSPENSION754
81964-003-54AUGMENTIN ES-600200 mL in 1 BOTTLEFOR SUSPENSION2004
81964-003-69AUGMENTIN ES-600125 mL in 1 BOTTLEFOR SUSPENSION1254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81964-003-54ML - Milliliter81964-003f9de5d35-82fe-42f0-aaef-2b0bdfd9dbf412023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81964-003AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [USANTIBIOTICS, LLC ]4Current NDC, Legacy NDC, 3 package rows20250112_59979859-8c9b-4173-a5e3-2e6312fd9d79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN59979859-8c9b-4173-a5e3-2e6312fd9d794
618028AUGMENTIN ES 600 MG / 42.9 MG in 5 mL Oral SuspensionPSN59979859-8c9b-4173-a5e3-2e6312fd9d794
618028amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension [Augmentin]SBD59979859-8c9b-4173-a5e3-2e6312fd9d794
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD59979859-8c9b-4173-a5e3-2e6312fd9d794
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY59979859-8c9b-4173-a5e3-2e6312fd9d794
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY59979859-8c9b-4173-a5e3-2e6312fd9d794
618028Augmentin ES 600 MG / 42.9 MG per 5 ML Oral SuspensionSY59979859-8c9b-4173-a5e3-2e6312fd9d794
618028Augmentin ES-600 (amoxicillin 600 MG / clavulanate 42.9 MG) per 5 ML Oral SuspensionSY59979859-8c9b-4173-a5e3-2e6312fd9d794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81964-003-518196400035175 mL in 1 BOTTLE (81964-003-51) 75 ml2022-07-150000-00-00NoNoCurrent
81964-003-5481964000354200 mL in 1 BOTTLE (81964-003-54) 200 ml2022-07-150000-00-00NoNoCurrent
81964-003-6981964000369125 mL in 1 BOTTLE (81964-003-69) 125 ml2022-07-150000-00-00NoNoCurrent