FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
61919-015
11-digit product format
619190015
Labeler code
61919
Product ID
61919-015_9c595e63-08b4-3358-e053-2995a90a54c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065322
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-015-332023-01-30C16284748780-1f386c64a-39bf-0266-e053-dadaa90a7c1aAMOXICILLIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-015-33AMOXICILLIN150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-015-33ML - Milliliter61919-015d0ed551a-4e40-4901-b5c9-42769bce2ac512014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-015AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]3Legacy NDC, 1 package rows20200118_8b28d3ac-0d6a-456b-a428-9ec6fe061d95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 50 MG/ML Oral SuspensionSCD8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8b28d3ac-0d6a-456b-a428-9ec6fe061d953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-015-3361919001533150 mL in 1 BOTTLE (61919-015-33) 150 ml2015-01-010000-00-00NoNoCurrent