FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-5863
11-digit product format
500905863
Labeler code
50090
Product ID
50090-5863_fa954a9d-1523-4cfe-8a58-d6988cec87fb
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
50090-5863-0Amoxicillin20 in 1 BOTTLETABLET, COATED205
50090-5863-1Amoxicillin14 in 1 BOTTLETABLET, COATED145
50090-5863-2Amoxicillin30 in 1 BOTTLETABLET, COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5863-0EA - Each50090-5863b3bbed02-9469-4872-964b-9da61cd1bc2612022-06-06
50090-5863-1EA - Each50090-5863480dfd5a-c6d8-427d-bd1b-35c8b6ec54e212022-09-12
50090-5863-2EA - Each50090-5863d2c58871-0126-4ee4-813d-d206344c7ff512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5863AMOXICILLIN TABLET, COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20231125_4eee2b38-ca84-421d-87e1-031bc5a3f3a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN4eee2b38-ca84-421d-87e1-031bc5a3f3a75
308194amoxicillin 875 MG Oral TabletSCD4eee2b38-ca84-421d-87e1-031bc5a3f3a75
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY4eee2b38-ca84-421d-87e1-031bc5a3f3a75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5863-05009058630020 TABLET, COATED in 1 BOTTLE (50090-5863-0) 2021-12-020000-00-00NoNoCurrent
50090-5863-15009058630114 TABLET, COATED in 1 BOTTLE (50090-5863-1) 2022-07-030000-00-00NoNoCurrent
50090-5863-25009058630230 TABLET, COATED in 1 BOTTLE (50090-5863-2) 2021-12-020000-00-00NoNoCurrent