AUGMENTIN ES-600

Product NDC
43598-003
11-digit product format
435980003
Labeler code
43598
Product ID
43598-003_0756200b-9953-58d9-b495-409d3cbf8c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr Reddys Laboratories Inc
Application
NDA050755
Marketing category
NDA
Marketing start
2012-10-31
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-003-51AUGMENTIN ES-60075 mL in 1 BOTTLEPOWDER, FOR SUSPENSION751
43598-003-54AUGMENTIN ES-600200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION2001
43598-003-69AUGMENTIN ES-600125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-003-51ML - Milliliter43598-0031abbfdcc-02da-4967-b1e4-3fd5f23900da12013-02-13
43598-003-54ML - Milliliter43598-00353c0b6eb-9eda-489c-8c70-ee2818fb10df12013-02-13
43598-003-69ML - Milliliter43598-00377a7471e-6f04-4888-8bb8-439aaad0e68812013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-003AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]1Legacy NDC, 3 package rows20121203_55aefa88-46fc-2b73-0819-0c2f88274852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN55aefa88-46fc-2b73-0819-0c2f882748521
618028AUGMENTIN ES 600 MG / 42.9 MG in 5 mL Oral SuspensionPSN55aefa88-46fc-2b73-0819-0c2f882748521
618028amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension [Augmentin]SBD55aefa88-46fc-2b73-0819-0c2f882748521
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD55aefa88-46fc-2b73-0819-0c2f882748521
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY55aefa88-46fc-2b73-0819-0c2f882748521
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY55aefa88-46fc-2b73-0819-0c2f882748521
618028Augmentin ES 600 MG / 42.9 MG per 5 ML Oral SuspensionSY55aefa88-46fc-2b73-0819-0c2f882748521
618028Augmentin ES-600 (amoxicillin 600 MG / clavulanate 42.9 MG) per 5 ML Oral SuspensionSY55aefa88-46fc-2b73-0819-0c2f882748521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43598-003-514359800035175 mL in 1 BOTTLE75 mlHistorical
43598-003-5443598000354200 mL in 1 BOTTLE200 mlHistorical
43598-003-6943598000369125 mL in 1 BOTTLE125 mlHistorical