FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
50090-6324
11-digit product format
500906324
Labeler code
50090
Product ID
50090-6324_a2a30785-599c-4436-a3cc-b4db011b7a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

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
50090-6324-0AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, COATED204
50090-6324-1AMOXICILLIN AND CLAVULANATE POTASSIUM10 in 1 BOTTLETABLET, COATED104
50090-6324-2AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BOTTLETABLET, COATED144
50090-6324-3AMOXICILLIN AND CLAVULANATE POTASSIUM28 in 1 BOTTLETABLET, COATED284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6324-0EA - Each50090-632402864758-5fe7-411e-bd44-05dec779b63a12024-06-10
50090-6324-1EA - Each50090-6324796251c8-7b70-415d-9744-bf8e9b8c6b2712024-06-10
50090-6324-2EA - Each50090-6324b861d207-dd60-4a17-a934-1340eadce95e12024-06-10
50090-6324-3EA - Each50090-6324e0aab6bb-b3c3-4404-9a26-51c0b7f2897b12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6324AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 4 package rows20240501_00cf4429-e37c-4490-b22d-3cd796124296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN00cf4429-e37c-4490-b22d-3cd7961242964
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 TabletSY00cf4429-e37c-4490-b22d-3cd7961242964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6324-05009063240020 TABLET, COATED in 1 BOTTLE (50090-6324-0) 2023-01-12NoNoHistorical
50090-6324-15009063240110 TABLET, COATED in 1 BOTTLE (50090-6324-1) 2023-01-12NoNoHistorical
50090-6324-25009063240214 TABLET, COATED in 1 BOTTLE (50090-6324-2) 2023-01-12NoNoHistorical
50090-6324-35009063240328 TABLET, COATED in 1 BOTTLE (50090-6324-3) 2023-01-12NoNoHistorical