FDA.reportPublic FDA data

Amoxicillin

Product NDC
55045-2992
11-digit product format
550452992
Labeler code
55045
Product ID
55045-2992_f3071984-c98d-464e-9211-08ac1600970e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dispensing Solutions Inc.
Application
ANDA065334
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
400 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
55045-2992-22019-10-21C16284748780-1956f9ecf-c951-621f-e053-dbdaa90a74adAmoxicillin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-2992-2Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55045-2992-2ML - Milliliter55045-29927caa4ac0-da30-4d9a-a19c-aa3a52222f1512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-2992AMOXICILLIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS INC.]2Legacy NDC, 1 package rows20100315_b18eca1d-0133-4266-829b-9a0bd925c4f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNb18eca1d-0133-4266-829b-9a0bd925c4f22
308189amoxicillin 80 MG/ML Oral SuspensionSCDb18eca1d-0133-4266-829b-9a0bd925c4f22
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYb18eca1d-0133-4266-829b-9a0bd925c4f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55045-2992-255045299202100 mL in 1 BOTTLE100 mlHistorical