FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
61919-401
11-digit product format
619190401
Labeler code
61919
Product ID
61919-401_0e877b33-af19-d857-e063-6394a90a08ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065334
Marketing category
ANDA
Marketing start
2014-01-01
Substance
AMOXICILLIN
Active strength
400 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
AMOXICILLIN400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308189, 617296

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-401-322020-06-19C16284748780-19d75b9cf-ee49-f424-e053-dadaa90a57ceAMOXICILLIN
61919-401-322020-01-31C16284748780-19d75b9cf-ee49-f424-e053-dadaa90a57ceAMOXICILLIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-401-32AMOXICILLIN100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-401-32ML - Milliliter61919-40100f585b3-478c-4197-a5ef-39f39bd31dfb12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-401AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]5Current NDC, Legacy NDC, 1 package rows20240110_0173e9de-a995-4386-bb65-8fc2bbf347f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN0173e9de-a995-4386-bb65-8fc2bbf347f95
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN0173e9de-a995-4386-bb65-8fc2bbf347f95
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD0173e9de-a995-4386-bb65-8fc2bbf347f95
308189amoxicillin 80 MG/ML Oral SuspensionSCD0173e9de-a995-4386-bb65-8fc2bbf347f95
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY0173e9de-a995-4386-bb65-8fc2bbf347f95
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY0173e9de-a995-4386-bb65-8fc2bbf347f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-401-3261919040132100 mL in 1 BOTTLE (61919-401-32) 100 ml2020-06-190000-00-00NoNoCurrent