FDA.reportPublic FDA data

Amoxicillin

Product NDC
66116-223
11-digit product format
661160223
Labeler code
66116
Product ID
66116-223_42a9d92c-f6d9-42b8-a58c-fd51cca49258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-223-152019-11-27C16284748780-19855d018-d3ee-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-223-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-223AMOXICILLIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130821_42a9d92c-f6d9-42b8-a58c-fd51cca49258.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN42a9d92c-f6d9-42b8-a58c-fd51cca492581
239191amoxicillin 50 MG/ML Oral SuspensionSCD42a9d92c-f6d9-42b8-a58c-fd51cca492581
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY42a9d92c-f6d9-42b8-a58c-fd51cca492581
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY42a9d92c-f6d9-42b8-a58c-fd51cca492581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66116-223-1566116022315150 mL in 1 BOTTLE150 mlHistorical