FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
42571-163
11-digit product format
425710163
Labeler code
42571
Product ID
42571-163_22ff093e-19eb-7dd4-e063-6394a90ac20d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA205187
Marketing category
ANDA
Marketing start
2021-07-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200; 28.5 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
Amoxicillin and Clavulanate Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN200 mg/5mL
CLAVULANATE POTASSIUM28.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617423, 617430

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-163-47Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-163AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [MICRO LABS LIMITED]8Current NDC, Legacy NDC, 1 package rows20240927_8ea86ac2-174b-4da0-963f-6a051dccbe36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN8ea86ac2-174b-4da0-963f-6a051dccbe368
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN8ea86ac2-174b-4da0-963f-6a051dccbe368
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD8ea86ac2-174b-4da0-963f-6a051dccbe368
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD8ea86ac2-174b-4da0-963f-6a051dccbe368
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY8ea86ac2-174b-4da0-963f-6a051dccbe368
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY8ea86ac2-174b-4da0-963f-6a051dccbe368
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY8ea86ac2-174b-4da0-963f-6a051dccbe368
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY8ea86ac2-174b-4da0-963f-6a051dccbe368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-163-4742571016347100 mL in 1 BOTTLE (42571-163-47) 100 ml2021-07-010000-00-00NoNoCurrent