FDA.reportPublic FDA data

Amoxicillin

Product NDC
63187-262
11-digit product format
631870262
Labeler code
63187
Product ID
63187-262_e6603270-d47e-47fc-bea9-0c1cea9f70aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
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
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-262-00Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1007
63187-262-50Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-262AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]7Current NDC, Legacy NDC, 2 package rows20240113_fcdaba34-373f-4d4e-8203-76f02e3bb00a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin 80 MG/ML Oral SuspensionSCDfcdaba34-373f-4d4e-8203-76f02e3bb00a7
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYfcdaba34-373f-4d4e-8203-76f02e3bb00a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-262-0063187026200100 mL in 1 BOTTLE (63187-262-00) 100 ml2015-02-020000-00-00NoNoCurrent
63187-262-506318702625050 mL in 1 BOTTLE (63187-262-50) 50 ml2024-01-11NoNoCurrent