Amoxicillin

Product NDC
50090-4078
11-digit product format
500904078
Labeler code
50090
Product ID
50090-4078_347e34aa-8dc6-4351-93e8-e91300987233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065119
Marketing category
ANDA
Marketing start
2003-02-26
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4078-0Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4078AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210417_19a5a6d9-8cd1-4013-96ea-e219d6a534ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin 80 MG/ML Oral SuspensionSCD19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY19a5a6d9-8cd1-4013-96ea-e219d6a534ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4078-05009040780075 mL in 1 BOTTLE (50090-4078-0) 75 ml2019-01-230000-00-00NoNoCurrent