FDA.reportPublic FDA data

Amoxicillin

Product NDC
53002-0130
11-digit product format
530020130
Labeler code
53002
Product ID
53002-0130_fa2f883d-0237-4370-9a26-eaad3ee367e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
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
2021-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-0130-12025-01-30C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-22025-01-30C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-12023-06-07C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-22023-06-07C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-12023-01-30C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-22023-01-30C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-12020-12-16C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-22020-12-16C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-12020-01-31C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
53002-0130-22020-01-31C16284748780-19d75b9d0-0c55-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0130-1Amoxicillin14 in 1 BOTTLETABLET, FILM COATED146
53002-0130-2Amoxicillin20 in 1 BOTTLETABLET, FILM COATED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0130AMOXICILLIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20230609_15906fc2-67ce-4c7e-abc9-73bd1d9f5498.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN15906fc2-67ce-4c7e-abc9-73bd1d9f54986
308194amoxicillin 875 MG Oral TabletSCD15906fc2-67ce-4c7e-abc9-73bd1d9f54986
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY15906fc2-67ce-4c7e-abc9-73bd1d9f54986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0130-15300201300114 TABLET, FILM COATED in 1 BOTTLE (53002-0130-1) 2017-10-010000-00-00NoNoCurrent
53002-0130-25300201300220 TABLET, FILM COATED in 1 BOTTLE (53002-0130-2) 2017-10-010000-00-00NoNoCurrent