FDA.reportPublic FDA data

Amoxicillin

Product NDC
81964-207
11-digit product format
819640207
Labeler code
81964
Product ID
81964-207_38f95a24-c32b-03cc-e063-6394a90aa51e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
USAntibiotics, LLC
Application
NDA050760
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-04-01
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

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81964-207-50Amoxicillin50 mL in 1 BOTTLEFOR SUSPENSION504
81964-207-51Amoxicillin75 mL in 1 BOTTLEFOR SUSPENSION754
81964-207-52Amoxicillin100 mL in 1 BOTTLEFOR SUSPENSION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81964-207-50ML - Milliliter81964-20763ebe54c-a12d-40c7-bcc9-57790676ad1d12024-05-16
81964-207-51ML - Milliliter81964-207559de125-5502-459f-b1b0-663c4467876312024-05-16
81964-207-52ML - Milliliter81964-2077e588f6d-7a8a-4da2-8d56-7dca9a46de0a12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81964-207AMOXICILLIN FOR SUSPENSION [USANTIBIOTICS, LLC]2Current NDC, 3 package rows20240522_06e5c07d-d95c-4955-8d35-a4703ca2359e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN06e5c07d-d95c-4955-8d35-a4703ca2359e4
308189amoxicillin 80 MG/ML Oral SuspensionSCD06e5c07d-d95c-4955-8d35-a4703ca2359e4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY06e5c07d-d95c-4955-8d35-a4703ca2359e4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN08100595-e6de-4a8a-a177-a94f849bbe9f1
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4528f48d-5bda-b307-e063-6294a90a294c1
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN575f97d5-ea44-481f-977d-7a28300b2a5f1
308189amoxicillin 80 MG/ML Oral SuspensionSCD08100595-e6de-4a8a-a177-a94f849bbe9f1
308189amoxicillin 80 MG/ML Oral SuspensionSCD4528f48d-5bda-b307-e063-6294a90a294c1
308189amoxicillin 80 MG/ML Oral SuspensionSCD575f97d5-ea44-481f-977d-7a28300b2a5f1
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY08100595-e6de-4a8a-a177-a94f849bbe9f1
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4528f48d-5bda-b307-e063-6294a90a294c1
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY575f97d5-ea44-481f-977d-7a28300b2a5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81964-207-508196402075050 mL in 1 BOTTLE (81964-207-50) 50 ml2024-04-01NoNoCurrent
81964-207-518196402075175 mL in 1 BOTTLE (81964-207-51) 75 ml2024-04-01NoNoCurrent
81964-207-5281964020752100 mL in 1 BOTTLE (81964-207-52) 100 ml2024-04-01NoNoCurrent