FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-0712
11-digit product format
500900712
Labeler code
50090
Product ID
50090-0712_c8637659-f869-4068-aef4-9cf3011af0c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065255
Marketing category
ANDA
Marketing start
2006-03-29
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 mg/1
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
50090-0712-02023-01-30C16284748780-1f386c649-f98a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Amoxicillin Tablets, USP safely and effectively. See full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration 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 caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0712-0Amoxicillin20 in 1 BOTTLETABLET, COATED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0712-0EA - Each50090-071218b1faa2-1a0a-481c-b21e-1cba9d0567e212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0712AMOXICILLIN TABLET, COATED [A-S MEDICATION SOLUTIONS]8Legacy NDC, 1 package rows20190325_8b05414e-745b-40e8-b3d0-07c4789e19ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN8b05414e-745b-40e8-b3d0-07c4789e19ea8
308194amoxicillin 875 MG Oral TabletSCD8b05414e-745b-40e8-b3d0-07c4789e19ea8
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY8b05414e-745b-40e8-b3d0-07c4789e19ea8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0712-05009007120020 TABLET, COATED in 1 BOTTLE (50090-0712-0) 2014-11-280000-00-00NoNoCurrent