FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-4320
11-digit product format
500904320
Labeler code
50090
Product ID
50090-4320_24a123af-3a80-49d8-b629-73aa24bf41e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4320-0Amoxicillin30 in 1 BOTTLECAPSULE302
50090-4320-1Amoxicillin40 in 1 BOTTLECAPSULE402
50090-4320-2Amoxicillin21 in 1 BOTTLECAPSULE212
50090-4320-5Amoxicillin15 in 1 BOTTLECAPSULE152
50090-4320-7Amoxicillin10 in 1 BOTTLECAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4320AMOXICILLIN CAPSULE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 5 package rows20190625_fadc4d59-d937-4f22-be6b-ce92fbb00482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin 500 MG Oral CapsuleSCDfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfadc4d59-d937-4f22-be6b-ce92fbb004822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4320-05009043200030 in 1 BOTTLEHistorical
50090-4320-15009043200140 CAPSULE in 1 BOTTLE (50090-4320-1) 40 capsule2019-05-300000-00-00NoNoCurrent
50090-4320-25009043200221 CAPSULE in 1 BOTTLE (50090-4320-2) 21 capsule2019-05-300000-00-00NoNoCurrent
50090-4320-55009043200515 CAPSULE in 1 BOTTLE (50090-4320-5) 15 capsule2019-05-300000-00-00NoNoCurrent
50090-4320-75009043200710 CAPSULE in 1 BOTTLE (50090-4320-7) 10 capsule2019-05-300000-00-00NoNoCurrent