FDA.reportPublic FDA data

Augmentin

Product NDC
71297-240
11-digit product format
712970240
Labeler code
71297
Product ID
71297-240_18975386-c292-a0cb-e063-6294a90aed18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Allegis Holdings, LLC
Application
NDA050575
Marketing category
NDA
Marketing start
2023-09-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
125; 31.25 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN125 mg/5mL
CLAVULANATE POTASSIUM31.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617302, 617333

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71297-240-34Augmentin75 mL in 1 BOTTLEFOR SUSPENSION754
71297-240-35Augmentin100 mL in 1 BOTTLEFOR SUSPENSION1004
71297-240-36Augmentin150 mL in 1 BOTTLEFOR SUSPENSION1504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71297-240-34ML - Milliliter71297-2406363ff06-7702-401d-9ee7-2d644f5fbf5a12024-05-16
71297-240-35ML - Milliliter71297-240adda923d-eb53-403c-9911-3efe3779444412023-12-05
71297-240-36ML - Milliliter71297-240129cec68-2dfc-4c60-9015-8cb861f3779e12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71297-240AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [ALLEGIS HOLDINGS, LLC]4Current NDC, 3 package rows20240518_04a31a42-d79e-bbb4-e063-6394a90a63ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617302amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral SuspensionPSN04a31a42-d79e-bbb4-e063-6394a90a63ee4
617333AUGMENTIN 125 MG / 31.25 MG in 5 mL Oral SuspensionPSN04a31a42-d79e-bbb4-e063-6394a90a63ee4
617333amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral Suspension [Augmentin]SBD04a31a42-d79e-bbb4-e063-6394a90a63ee4
617302amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral SuspensionSCD04a31a42-d79e-bbb4-e063-6394a90a63ee4
617302amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral SuspensionSY04a31a42-d79e-bbb4-e063-6394a90a63ee4
617302amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral SuspensionSY04a31a42-d79e-bbb4-e063-6394a90a63ee4
617333Augmentin (amoxicillin 125 MG / clavulanate 31.25 MG) per 5 ML Oral SuspensionSY04a31a42-d79e-bbb4-e063-6394a90a63ee4
617333Augmentin 125 MG / 31.25 MG per 5 ML Oral SuspensionSY04a31a42-d79e-bbb4-e063-6394a90a63ee4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71297-240-347129702403475 mL in 1 BOTTLE (71297-240-34) 75 ml2024-02-20NoNoCurrent
71297-240-3571297024035100 mL in 1 BOTTLE (71297-240-35) 100 ml2023-09-01NoNoCurrent
71297-240-3671297024036150 mL in 1 BOTTLE (71297-240-36) 150 ml2023-09-01NoNoCurrent