FDA.reportPublic FDA data

Amoxicillin

Product NDC
33261-602
11-digit product format
332610602
Labeler code
33261
Product ID
33261-602_1135c0be-16b1-4427-aaa6-bd81d53ed2fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065322
Marketing category
ANDA
Marketing start
2006-06-19
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
125 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-602-012020-01-31C16284748780-19d75b9d0-ffbe-f424-e053-dadaa90a57ceAmoxicillin Powder for Oral Suspension Rx Only 11/2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-602-01Amoxicillin150 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION1506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-602-01ML - Milliliter33261-602aab8b2f8-e387-4c57-b776-0bc973c75d3a12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-602AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]6Legacy NDC, 1 package rows20140327_cb78a002-8505-4e38-9cc1-4a8bd59c2902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSNcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin 25 MG/ML Oral SuspensionSCDcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSYcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin 125 MG per 5 ML Oral SuspensionSYcb78a002-8505-4e38-9cc1-4a8bd59c29026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-602-0133261060201150 mL in 1 BOTTLE, PLASTIC150 mlHistorical