FDA.reportPublic FDA data

Amoxicillin

Product NDC
67253-144
11-digit product format
672530144
Labeler code
67253
Product ID
67253-144_0972267b-1a1b-40da-b95c-2dc7be21720e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
DAVA Pharmaceuticals Inc
Application
ANDA064076
Marketing category
ANDA
Marketing start
2014-08-01
Marketing end
2021-02-28
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN7f813093-98a2-452a-b6f1-132fe40f76c74
308191amoxicillin 500 MG Oral CapsulePSN7f813093-98a2-452a-b6f1-132fe40f76c74
308182amoxicillin 250 MG Oral CapsuleSCD7f813093-98a2-452a-b6f1-132fe40f76c74
308191amoxicillin 500 MG Oral CapsuleSCD7f813093-98a2-452a-b6f1-132fe40f76c74
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY7f813093-98a2-452a-b6f1-132fe40f76c74
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY7f813093-98a2-452a-b6f1-132fe40f76c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67253-144-5067253014450500 CAPSULE in 1 BOTTLE (67253-144-50) 500 capsule2014-08-012021-02-28NoNoCurrent