FDA.reportPublic FDA data

Amoxicillin

Product NDC
53217-210
11-digit product format
532170210
Labeler code
53217
Product ID
53217-210_97c3a14b-67e2-4e2e-b06c-5f3668162027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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
53217-210-142020-01-31C16284748780-19d75b9cf-d2a4-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
53217-210-202020-01-31C16284748780-19d75b9cf-d2a4-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
53217-210-282020-01-31C16284748780-19d75b9cf-d2a4-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
53217-210-14Amoxicillin14 in 1 BOTTLETABLET, FILM COATED141
53217-210-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED201
53217-210-28Amoxicillin28 in 1 BOTTLETABLET, FILM COATED281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-210-14EA - Each53217-210f142d3b4-51d4-4f80-838e-05c43ccf265912017-03-06
53217-210-28EA - Each53217-2104f31a985-c595-4f18-978c-93643bc3141712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-210AMOXICILLIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170228_a24a05ea-324d-4b2b-be71-6107e2b57fb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSNa24a05ea-324d-4b2b-be71-6107e2b57fb41
308194amoxicillin 875 MG Oral TabletSCDa24a05ea-324d-4b2b-be71-6107e2b57fb41
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYa24a05ea-324d-4b2b-be71-6107e2b57fb41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-210-145321702101414 in 1 BOTTLEHistorical
53217-210-205321702102020 in 1 BOTTLEHistorical
53217-210-285321702102828 in 1 BOTTLEHistorical