FDA.reportPublic FDA data

AUGMENTIN

Product NDC
43598-012
11-digit product format
435980012
Labeler code
43598
Product ID
43598-012_81f11e22-8d19-4974-87d5-aa983d5ea945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
NDA050575
Marketing category
NDA
Marketing start
1990-10-22
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
125 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-012-512020-01-31C16284748780-19d75b9d0-fca3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN ® (amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused b
43598-012-522020-01-31C16284748780-19d75b9d0-fca3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN ® (amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused b
43598-012-532020-01-31C16284748780-19d75b9d0-fca3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN ® (amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-012-51AUGMENTIN75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION756
43598-012-52AUGMENTIN100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1006
43598-012-53AUGMENTIN150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-012-51ML - Milliliter43598-01273c20da8-74d1-4789-9c42-08cb20d767cf12012-07-24
43598-012-52ML - Milliliter43598-01263af0fff-dab7-48ef-a25c-989827b66d1812012-07-24
43598-012-53ML - Milliliter43598-01250731d85-d4c5-4520-9f93-8bbaedb5820812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-012AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC]6Legacy NDC, 3 package rows20160913_174cc098-fe49-4f1a-87e2-601c7573f0db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617302amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral SuspensionPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
617333AUGMENTIN 125 MG / 31.25 MG in 5 mL Oral SuspensionPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
824186AUGMENTIN 250 MG / 125 MG Oral TabletPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
617339AUGMENTIN 250 MG / 62.5 MG in 5 mL Oral SuspensionPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
824190AUGMENTIN 500 MG / 125 MG Oral TabletPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
824194AUGMENTIN 875 MG / 125 MG Oral TabletPSN174cc098-fe49-4f1a-87e2-601c7573f0db6
617333amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral Suspension [Augmentin]SBD174cc098-fe49-4f1a-87e2-601c7573f0db6
824186amoxicillin 250 MG / clavulanate 125 MG Oral Tablet [Augmentin]SBD174cc098-fe49-4f1a-87e2-601c7573f0db6
617339amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension [Augmentin]SBD174cc098-fe49-4f1a-87e2-601c7573f0db6
824190amoxicillin 500 MG / clavulanate 125 MG Oral Tablet [Augmentin]SBD174cc098-fe49-4f1a-87e2-601c7573f0db6
824194amoxicillin 875 MG / clavulanate 125 MG Oral Tablet [Augmentin]SBD174cc098-fe49-4f1a-87e2-601c7573f0db6
617302amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral SuspensionSCD174cc098-fe49-4f1a-87e2-601c7573f0db6
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD174cc098-fe49-4f1a-87e2-601c7573f0db6
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCD174cc098-fe49-4f1a-87e2-601c7573f0db6
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD174cc098-fe49-4f1a-87e2-601c7573f0db6
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD174cc098-fe49-4f1a-87e2-601c7573f0db6
617302amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY174cc098-fe49-4f1a-87e2-601c7573f0db6
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617302amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617333Augmentin (amoxicillin 125 MG / clavulanate 31.25 MG) per 5 ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617339Augmentin (amoxicillin 250 MG / clavulanate 62.5 MG) per 5 ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617333Augmentin 125 MG / 31.25 MG per 5 ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
617339Augmentin 250 mg / 62.5 MG per 5 ML Oral SuspensionSY174cc098-fe49-4f1a-87e2-601c7573f0db6
824186Augmentin 250-mg Oral TabletSY174cc098-fe49-4f1a-87e2-601c7573f0db6
824190Augmentin 500-mg Oral TabletSY174cc098-fe49-4f1a-87e2-601c7573f0db6
824194Augmentin 875-mg Oral TabletSY174cc098-fe49-4f1a-87e2-601c7573f0db6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43598-012-514359800125175 mL in 1 BOTTLE75 mlHistorical
43598-012-5243598001252100 mL in 1 BOTTLE100 mlHistorical
43598-012-5343598001253150 mL in 1 BOTTLE150 mlHistorical