FDA.reportPublic FDA data

Amoxicillin

Product NDC
63187-591
11-digit product format
631870591
Labeler code
63187
Product ID
63187-591_a694d973-bbd9-4bdf-82ee-fc4688c101d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA064076
Marketing category
ANDA
Marketing start
1994-09-30
Substance
AMOXICILLIN
Active strength
250 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308182

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
63187-591-20Amoxicillin20 in 1 BOTTLECAPSULE203
63187-591-21Amoxicillin21 in 1 BOTTLECAPSULE213
63187-591-28Amoxicillin28 in 1 BOTTLECAPSULE283
63187-591-30Amoxicillin30 in 1 BOTTLECAPSULE303
63187-591-40Amoxicillin40 in 1 BOTTLECAPSULE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-591AMOXICILLIN CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20210113_9528a356-4101-4be2-a7e2-b0659e169e1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN9528a356-4101-4be2-a7e2-b0659e169e1a3
308182amoxicillin 250 MG Oral CapsuleSCD9528a356-4101-4be2-a7e2-b0659e169e1a3
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY9528a356-4101-4be2-a7e2-b0659e169e1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-591-206318705912020 CAPSULE in 1 BOTTLE (63187-591-20) 20 capsule2018-12-010000-00-00NoNoCurrent
63187-591-216318705912121 CAPSULE in 1 BOTTLE (63187-591-21) 21 capsule2018-12-010000-00-00NoNoCurrent
63187-591-286318705912828 CAPSULE in 1 BOTTLE (63187-591-28) 28 capsule2018-12-010000-00-00NoNoCurrent
63187-591-306318705913030 CAPSULE in 1 BOTTLE (63187-591-30) 30 capsule2018-12-010000-00-00NoNoCurrent
63187-591-406318705914040 CAPSULE in 1 BOTTLE (63187-591-40) 40 capsule2018-12-010000-00-00NoNoCurrent