FDA.reportPublic FDA data

Amoxicillin

Product NDC
63187-186
11-digit product format
631870186
Labeler code
63187
Product ID
63187-186_336edd44-77fc-48f7-987c-3432ae79ffa1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
Substance
AMOXICILLIN
Active strength
250 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
AMOXICILLIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191

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
63187-186-00Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005
63187-186-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-186AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20220609_de792ac6-4b3d-4d34-8e50-030b5bd830d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNde792ac6-4b3d-4d34-8e50-030b5bd830d75
239191amoxicillin 50 MG/ML Oral SuspensionSCDde792ac6-4b3d-4d34-8e50-030b5bd830d75
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYde792ac6-4b3d-4d34-8e50-030b5bd830d75
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYde792ac6-4b3d-4d34-8e50-030b5bd830d75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-186-0063187018600100 mL in 1 BOTTLE (63187-186-00) 100 ml1990-09-300000-00-00NoNoCurrent
63187-186-1563187018615150 mL in 1 BOTTLE (63187-186-15) 150 ml2018-11-010000-00-00NoNoCurrent