FDA.reportPublic FDA data

Amoxicillin

Product NDC
53002-2160
11-digit product format
530022160
Labeler code
53002
Product ID
53002-2160_700b79b4-7c37-415a-990d-3f97fb1e9e84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-11-09
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 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
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
53002-2160-12025-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-22025-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-32025-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-42025-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-52025-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-62025-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-12023-06-07C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-22023-06-07C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-32023-06-07C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-42023-06-07C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-52023-06-07C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-62023-06-07C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-12023-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-22023-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-32023-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-42023-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-52023-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-62023-01-30C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-12020-02-19C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-22020-02-19C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-32020-02-19C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-42020-02-19C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-52020-02-19C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-62020-02-19C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-12020-01-31C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-22020-01-31C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-32020-01-31C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-42020-01-31C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-52020-01-31C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
53002-2160-62020-01-31C16284748780-19d75b9d0-63af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2160-1Amoxicillin9 in 1 BOTTLECAPSULE911
53002-2160-2Amoxicillin15 in 1 BOTTLECAPSULE1511
53002-2160-3Amoxicillin21 in 1 BOTTLECAPSULE2111
53002-2160-4Amoxicillin30 in 1 BOTTLECAPSULE3011
53002-2160-5Amoxicillin40 in 1 BOTTLECAPSULE4011
53002-2160-6Amoxicillin60 in 1 BOTTLECAPSULE6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2160AMOXICILLIN CAPSULE [RPK PHARMACEUTICALS, INC.]11Legacy NDC, 6 package rows20230609_23979212-e989-4a8e-8dc8-46c5b4ecd590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin 500 MG Oral CapsulePSN23979212-e989-4a8e-8dc8-46c5b4ecd59011
308182amoxicillin 250 MG Oral CapsuleSCD23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin 500 MG Oral CapsuleSCD23979212-e989-4a8e-8dc8-46c5b4ecd59011
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY23979212-e989-4a8e-8dc8-46c5b4ecd59011
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY23979212-e989-4a8e-8dc8-46c5b4ecd59011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2160-1530022160019 CAPSULE in 1 BOTTLE (53002-2160-1) 9 capsule2017-10-010000-00-00NoNoCurrent
53002-2160-25300221600215 CAPSULE in 1 BOTTLE (53002-2160-2) 15 capsule2017-10-010000-00-00NoNoCurrent
53002-2160-35300221600321 CAPSULE in 1 BOTTLE (53002-2160-3) 21 capsule2017-10-010000-00-00NoNoCurrent
53002-2160-45300221600430 CAPSULE in 1 BOTTLE (53002-2160-4) 30 capsule2017-10-010000-00-00NoNoCurrent
53002-2160-55300221600540 CAPSULE in 1 BOTTLE (53002-2160-5) 40 capsule2017-10-010000-00-00NoNoCurrent
53002-2160-65300221600660 CAPSULE in 1 BOTTLE (53002-2160-6) 60 capsule2017-10-010000-00-00NoNoCurrent