FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-6469
11-digit product format
500906469
Labeler code
50090
Product ID
50090-6469_94dbe808-3c56-4d9c-9243-0647165bd692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204030
Marketing category
ANDA
Marketing start
2014-09-15
Substance
AMOXICILLIN
Active strength
250 mg/5mL
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
AMOXICILLIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191

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
50090-6469-0Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6469-0ML - Milliliter50090-6469c704f368-70a8-407d-b634-a7f8ea0c0bdd12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6469AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]3Current NDC, 1 package rows20240501_efc66d77-1733-41e1-9aed-7c10a4b4ba96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNefc66d77-1733-41e1-9aed-7c10a4b4ba963
239191amoxicillin 50 MG/ML Oral SuspensionSCDefc66d77-1733-41e1-9aed-7c10a4b4ba963
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYefc66d77-1733-41e1-9aed-7c10a4b4ba963
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYefc66d77-1733-41e1-9aed-7c10a4b4ba963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6469-05009064690080 mL in 1 BOTTLE (50090-6469-0) 80 ml2023-05-08NoNoCurrent