FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
81964-221
11-digit product format
819640221
Labeler code
81964
Product ID
81964-221_3854c6ad-10f7-dae3-e063-6294a90ae00a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
USAntibiotics, LLC
Application
NDA050720
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-11-21
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 125 mg/1; mg/1
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
AMOXICILLIN875 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562508, 617302, 617322

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
81964-221-01AMOXICILLIN AND CLAVULANATE POTASSIUM100 in 1 BOTTLETABLET, COATED1005
81964-221-14AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, COATED205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81964-221-01EA - Each81964-22104d0ecac-0904-4bed-8a6f-a2b497b9d8ba12024-12-10
81964-221-14EA - Each81964-221340e1d46-9661-446f-87ec-2ae66bae31f512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81964-221AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION [USANTIBIOTICS, LLC]4Current NDC, Legacy NDC, 2 package rows20240518_c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617302amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral SuspensionPSNc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSNc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617302amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral SuspensionSCDc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCDc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617302amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral SuspensionSYc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSYc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617302amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral SuspensionSYc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSYc4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f35
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN00cf4429-e37c-4490-b22d-3cd7961242964
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN1b8a6312-ae47-45fb-ba5e-eedbc176afa04
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD1b8a6312-ae47-45fb-ba5e-eedbc176afa04
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD00cf4429-e37c-4490-b22d-3cd7961242964
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY1b8a6312-ae47-45fb-ba5e-eedbc176afa04
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY00cf4429-e37c-4490-b22d-3cd7961242964
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN3ed5838f-2175-4a1a-ab5a-a222a6da4e893
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD3ed5838f-2175-4a1a-ab5a-a222a6da4e893
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY3ed5838f-2175-4a1a-ab5a-a222a6da4e893
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN0d40bc70-8f47-48c2-a7c6-ba7db9cace741
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD0d40bc70-8f47-48c2-a7c6-ba7db9cace741
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY0d40bc70-8f47-48c2-a7c6-ba7db9cace741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81964-221-0181964022101100 TABLET, COATED in 1 BOTTLE (81964-221-01) 2024-05-01NoNoCurrent
81964-221-148196402211420 TABLET, COATED in 1 BOTTLE (81964-221-14) 2022-11-210000-00-00NoNoCurrent