FDA.reportPublic FDA data

amoxicillin and clavulanate potassium

Product NDC
73043-010
11-digit product format
730430010
Labeler code
73043
Product ID
73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Devatis, Inc.
Application
ANDA210374
Marketing category
ANDA
Marketing start
2024-07-05
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250; 62.5 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
AMOXICILLIN250 mg/5mL
CLAVULANATE POTASSIUM62.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617322

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
73043-010-01amoxicillin and clavulanate potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION755
73043-010-02amoxicillin and clavulanate potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005
73043-010-03amoxicillin and clavulanate potassium150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-010-01ML - Milliliter73043-010c113ac8b-a061-466c-aa77-4d7445d8741a12025-01-14
73043-010-02ML - Milliliter73043-010d98583a1-2a1d-45d7-9b27-ed31dfe2f0b612025-01-14
73043-010-03ML - Milliliter73043-010032d6211-fa60-46b7-89ba-da866e77508c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73043-010AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DEVATIS, INC.]5Current NDC, 3 package rows20250312_b0b2e164-e70d-471f-92ce-abdac6cb405f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSNb0b2e164-e70d-471f-92ce-abdac6cb405f5
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCDb0b2e164-e70d-471f-92ce-abdac6cb405f5
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSYb0b2e164-e70d-471f-92ce-abdac6cb405f5
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSYb0b2e164-e70d-471f-92ce-abdac6cb405f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-010-017304300100175 mL in 1 BOTTLE (73043-010-01) 75 ml2024-08-15NoNoHistorical
73043-010-0273043001002100 mL in 1 BOTTLE (73043-010-02) 100 ml2024-09-01NoNoHistorical
73043-010-0373043001003150 mL in 1 BOTTLE (73043-010-03) 150 ml2024-07-05NoNoHistorical