FDA.reportPublic FDA data

Amoxicillin

Product NDC
33261-460
11-digit product format
332610460
Labeler code
33261
Product ID
33261-460_02811f2f-f4d1-44c0-9ba3-f8dcba5c3cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065322
Marketing category
ANDA
Marketing start
2006-06-19
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-460-012020-01-31C16284748780-19d75b9d0-231d-f424-e053-dadaa90a57ceHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Amoxicillin Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin Powder for Oral Suspension, USP. Amoxicillin Powder for Oral Suspension, USP 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 trea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-460-01Amoxicillin150 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-460AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20140328_754641ad-5bca-45d6-a6ff-c06d4e3db47a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 50 MG/ML Oral SuspensionSCD754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY754641ad-5bca-45d6-a6ff-c06d4e3db47a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-460-0133261046001150 mL in 1 BOTTLE, PLASTIC150 mlHistorical