FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
73043-008
11-digit product format
730430008
Labeler code
73043
Product ID
73043-008_2d94ce8d-5992-45c0-bf59-a8e12d226462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Devatis Inc.
Application
ANDA209351
Marketing category
ANDA
Marketing start
2024-11-01
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
Amoxicillin and Clavulanate Potassium
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

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
73043-008-01Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION752
73043-008-02Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1252
73043-008-03Amoxicillin and Clavulanate Potassium200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-008-01ML - Milliliter73043-008ff159d32-b0ce-4f7f-bddb-8cef11d0d22d12025-08-11
73043-008-02ML - Milliliter73043-008a89c6555-061a-4ca7-be69-3984fc0174bb12025-08-11
73043-008-03ML - Milliliter73043-008bb75e37a-dfaf-41ee-aefd-3b0ce46c78af12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73043-008AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DEVATIS INC.]2Current NDC, 3 package rows20250316_a884cff6-bffd-41fd-904c-c694c995f338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNa884cff6-bffd-41fd-904c-c694c995f3382
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDa884cff6-bffd-41fd-904c-c694c995f3382
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYa884cff6-bffd-41fd-904c-c694c995f3382
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYa884cff6-bffd-41fd-904c-c694c995f3382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-008-017304300080175 mL in 1 BOTTLE (73043-008-01) 75 ml2024-11-01NoNoCurrent
73043-008-0273043000802125 mL in 1 BOTTLE (73043-008-02) 125 ml2024-11-01NoNoCurrent
73043-008-0373043000803200 mL in 1 BOTTLE (73043-008-03) 200 ml2024-11-01NoNoCurrent