Amoxicillin

Product NDC
82804-134
11-digit product format
828040134
Labeler code
82804
Product ID
82804-134_c8e5ad7d-09b7-41d9-8cb0-467b3e8df74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
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
82804-134-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-134AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1Current NDC, 1 package rows20240822_c8e5ad7d-09b7-41d9-8cb0-467b3e8df74f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNc8e5ad7d-09b7-41d9-8cb0-467b3e8df74f1
239191amoxicillin 50 MG/ML Oral SuspensionSCDc8e5ad7d-09b7-41d9-8cb0-467b3e8df74f1
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYc8e5ad7d-09b7-41d9-8cb0-467b3e8df74f1
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYc8e5ad7d-09b7-41d9-8cb0-467b3e8df74f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-134-1582804013415150 mL in 1 BOTTLE (82804-134-15) 150 ml2024-08-15NoNoCurrent