FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-5880
11-digit product format
500905880
Labeler code
50090
Product ID
50090-5880_33b6a1ef-8834-4091-9d82-a36696ae7ad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065255
Marketing category
ANDA
Marketing start
2006-03-29
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5880-0Amoxicillin20 in 1 BOTTLETABLET, COATED205
50090-5880-1Amoxicillin14 in 1 BOTTLETABLET, COATED145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5880-0EA - Each50090-58800991744e-530a-4a86-8c4d-5ee56b9c192912022-06-06
50090-5880-1EA - Each50090-588040401004-c9d1-4c85-be8b-2a51c85b234412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5880AMOXICILLIN TABLET, COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240824_85721bc3-37eb-4db6-8a40-8a1412ac953a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN85721bc3-37eb-4db6-8a40-8a1412ac953a5
308194amoxicillin 875 MG Oral TabletSCD85721bc3-37eb-4db6-8a40-8a1412ac953a5
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY85721bc3-37eb-4db6-8a40-8a1412ac953a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5880-05009058800020 TABLET, COATED in 1 BOTTLE (50090-5880-0) 2021-12-210000-00-00NoNoCurrent
50090-5880-15009058800114 TABLET, COATED in 1 BOTTLE (50090-5880-1) 2024-08-16NoNoHistorical