FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
71205-036
11-digit product format
712050036
Labeler code
71205
Product ID
71205-036_d8353a21-2ed6-4faa-b0a0-f35aae947ac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201091
Marketing category
ANDA
Marketing start
2011-12-20
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
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-036-12Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1256
71205-036-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION756

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-036-12ML - Milliliter71205-03663691114-a5df-4dad-aaa3-6987f120aa5a12021-04-08
71205-036-75ML - Milliliter71205-036e3c68d9f-45e0-4a29-9063-39e10a2403a612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-036AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]6Current NDC, Legacy NDC, 2 package rows20220402_bb75eb89-2579-4189-8dd2-40ae8727fe7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYbb75eb89-2579-4189-8dd2-40ae8727fe7c6
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYbb75eb89-2579-4189-8dd2-40ae8727fe7c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-036-1271205003612125 mL in 1 BOTTLE (71205-036-12) 125 ml2018-05-010000-00-00NoNoCurrent
71205-036-757120500367575 mL in 1 BOTTLE (71205-036-75) 75 ml2020-09-300000-00-00NoNoCurrent