FDA.reportPublic FDA data

Amoxicillin

Product NDC
50436-5101
11-digit product format
504365101
Labeler code
50436
Product ID
50436-5101_163b6898-4fdb-4fbb-9652-78e3580555e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
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
2020-12-31
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
50436-5101-02021-01-29C16284748780-1ba0f9c33-3632-a910-e053-dadaa90a0b85These 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 Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-5101-0Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-5101AMOXICILLIN POWDER, FOR SUSPENSION [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20160506_c721aa04-44c9-4326-9647-8a012ecf3086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNc721aa04-44c9-4326-9647-8a012ecf30862
308189amoxicillin 80 MG/ML Oral SuspensionSCDc721aa04-44c9-4326-9647-8a012ecf30862
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYc721aa04-44c9-4326-9647-8a012ecf30862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-5101-050436510100100 mL in 1 BOTTLE100 mlHistorical