FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-3516
11-digit product format
500903516
Labeler code
50090
Product ID
50090-3516_a6fbfce5-5f49-4976-abac-9c1c9923371e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065325
Marketing category
ANDA
Marketing start
2006-06-19
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
200 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3516-02023-01-30C16284748780-1f386c649-fcf5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension. AMOXICILLIN for Oral Suspension for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly suspected to be caus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3516-0Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3516AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20200122_29b7a0d1-4dfd-4c67-aae6-d9aaef5f8230.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN29b7a0d1-4dfd-4c67-aae6-d9aaef5f82304
313850amoxicillin 40 MG/ML Oral SuspensionSCD29b7a0d1-4dfd-4c67-aae6-d9aaef5f82304
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY29b7a0d1-4dfd-4c67-aae6-d9aaef5f82304
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY29b7a0d1-4dfd-4c67-aae6-d9aaef5f82304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3516-050090351600100 mL in 1 BOTTLE (50090-3516-0) 100 ml2018-07-260000-00-00NoNoCurrent