FDA.reportPublic FDA data

Amoxicillin

Product NDC
63187-729
11-digit product format
631870729
Labeler code
63187
Product ID
63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308194

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-729-14Amoxicillin14 in 1 BOTTLETABLET, FILM COATED143
63187-729-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED203
63187-729-21Amoxicillin21 in 1 BOTTLETABLET, FILM COATED213
63187-729-28Amoxicillin28 in 1 BOTTLETABLET, FILM COATED283
63187-729-30Amoxicillin30 in 1 BOTTLETABLET, FILM COATED303
63187-729-40Amoxicillin40 in 1 BOTTLETABLET, FILM COATED403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-729AMOXICILLIN TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20191121_586a5911-e30b-40ed-a056-9e67920ca951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin 875 MG Oral TabletSCD586a5911-e30b-40ed-a056-9e67920ca9513
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY586a5911-e30b-40ed-a056-9e67920ca9513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-729-146318707291414 TABLET, FILM COATED in 1 BOTTLE (63187-729-14) 2016-08-010000-00-00NoNoCurrent
63187-729-206318707292020 TABLET, FILM COATED in 1 BOTTLE (63187-729-20) 2016-08-010000-00-00NoNoCurrent
63187-729-216318707292121 TABLET, FILM COATED in 1 BOTTLE (63187-729-21) 2016-08-010000-00-00NoNoCurrent
63187-729-286318707292828 TABLET, FILM COATED in 1 BOTTLE (63187-729-28) 2016-08-010000-00-00NoNoCurrent
63187-729-306318707293030 TABLET, FILM COATED in 1 BOTTLE (63187-729-30) 2016-08-010000-00-00NoNoCurrent
63187-729-406318707294040 TABLET, FILM COATED in 1 BOTTLE (63187-729-40) 2016-08-010000-00-00NoNoCurrent