FDA.reportPublic FDA data

Amoxicillin

Product NDC
45865-594
11-digit product format
458650594
Labeler code
45865
Product ID
45865-594_9adc29d7-203d-24be-e053-2995a90a9c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA065228
Marketing category
ANDA
Marketing start
2005-07-13
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
45865-594-202023-01-30C16284748780-1f386c64a-4835-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-594-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-594AMOXICILLIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9adc29c6-79e0-3ede-e053-2a95a90a6721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN9adc29c6-79e0-3ede-e053-2a95a90a67211
308194amoxicillin 875 MG Oral TabletSCD9adc29c6-79e0-3ede-e053-2a95a90a67211
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY9adc29c6-79e0-3ede-e053-2a95a90a67211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-594-204586505942020 TABLET, FILM COATED in 1 BOTTLE (45865-594-20) 2018-12-120000-00-00NoNoCurrent