Amoxicillin

Product NDC
12634-874
11-digit product format
126340874
Labeler code
12634
Product ID
12634-874_271ddc63-b31c-2f46-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca 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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-874-71Amoxicillin30 in 1 BOTTLETABLET, FILM COATED302
12634-874-80Amoxicillin20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-874AMOXICILLIN TABLET, FILM COATED [APOTHECA INC.]2Legacy NDC, 2 package rows20151218_271ddc63-b31b-2f46-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin 875 MG Oral TabletSCD271ddc63-b31b-2f46-e054-00144ff8d46c2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY271ddc63-b31b-2f46-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-874-711263408747130 in 1 BOTTLEHistorical
12634-874-801263408748020 in 1 BOTTLEHistorical