FDA.reportPublic FDA data

Amoxicillin

Product NDC
65862-706
11-digit product format
658620706
Labeler code
65862
Product ID
65862-706_f4a410c9-3a78-48f9-8195-915896a974ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204030
Marketing category
ANDA
Marketing start
2014-09-15
Substance
AMOXICILLIN
Active strength
125 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
AMOXICILLIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191, 313797

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
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-706-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10013
65862-706-55Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION15013
65862-706-80Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION8013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-706AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 3 package rows20240614_234d0dfc-cb24-413f-b798-129c73eb848e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN234d0dfc-cb24-413f-b798-129c73eb848e13
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN234d0dfc-cb24-413f-b798-129c73eb848e13
313797amoxicillin 25 MG/ML Oral SuspensionSCD234d0dfc-cb24-413f-b798-129c73eb848e13
239191amoxicillin 50 MG/ML Oral SuspensionSCD234d0dfc-cb24-413f-b798-129c73eb848e13
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY234d0dfc-cb24-413f-b798-129c73eb848e13
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY234d0dfc-cb24-413f-b798-129c73eb848e13
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY234d0dfc-cb24-413f-b798-129c73eb848e13
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY234d0dfc-cb24-413f-b798-129c73eb848e13
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN7db086c6-a56b-4848-9eec-abaaff9f5b6f3
313797amoxicillin 25 MG/ML Oral SuspensionSCD7db086c6-a56b-4848-9eec-abaaff9f5b6f3
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY7db086c6-a56b-4848-9eec-abaaff9f5b6f3
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY7db086c6-a56b-4848-9eec-abaaff9f5b6f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-706-0165862070601100 mL in 1 BOTTLE (65862-706-01) 100 ml2014-09-150000-00-00NoNoCurrent
65862-706-5565862070655150 mL in 1 BOTTLE (65862-706-55) 150 ml2014-09-150000-00-00NoNoCurrent
65862-706-806586207068080 mL in 1 BOTTLE (65862-706-80) 80 ml2014-09-150000-00-00NoNoCurrent