AMOXIL

Product NDC
61919-716
11-digit product format
619190716
Labeler code
61919
Product ID
61919-716_f21546be-be21-4cc9-e053-2995a90af7cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Direct_Rx
Application
ANDA065322
Marketing category
ANDA
Marketing start
2016-03-04
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
2024-12-31
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
61919-716-332025-01-30C16284748780-12cef2736-ad86-d83d-e063-dadaa90ab31fAMOXICILLIN ORAL SUSP 250mg/5mL 150mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-716-33AMOXIL5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-716-33ML - Milliliter61919-7164cacfd7f-6241-4d72-be11-dc3ff05b788712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-716AMOXIL (AMOXICILLIN) POWDER, FOR SUSPENSION [DIRECT_RX]2Legacy NDC, 1 package rows20230113_330a6a2e-1224-557c-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-716-33619190716335 mL in 1 BOTTLE (61919-716-33) 5 ml2016-03-040000-00-00NoNoCurrent