FDA.reportPublic FDA data

Amoxicillin

Product NDC
53217-249
11-digit product format
532170249
Labeler code
53217
Product ID
53217-249_4951ef6f-4443-40ae-a4b4-2825ba4dd7b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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
53217-249-012020-01-31C16284748780-19d75b9cf-ed32-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, 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 susp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-249-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-249-01ML - Milliliter53217-2490aed3093-d826-4fc2-b6c2-6dc15962117412016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-249AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20161206_536a2553-ddb3-496f-bc6f-d4e399ffb9d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN536a2553-ddb3-496f-bc6f-d4e399ffb9d21
313850amoxicillin 40 MG/ML Oral SuspensionSCD536a2553-ddb3-496f-bc6f-d4e399ffb9d21
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY536a2553-ddb3-496f-bc6f-d4e399ffb9d21
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY536a2553-ddb3-496f-bc6f-d4e399ffb9d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-249-0153217024901100 mL in 1 BOTTLE100 mlHistorical