FDA.reportPublic FDA data

Amoxicillin

Product NDC
68788-8209
11-digit product format
687888209
Labeler code
68788
Product ID
68788-8209_5ddd80af-1ce9-4995-b1e5-0b0faec69859
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Phamraceuticals Inc.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2022-09-08
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308191

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
68788-8209-2Amoxicillin21 in 1 BOTTLECAPSULE215
68788-8209-3Amoxicillin30 in 1 BOTTLECAPSULE305
68788-8209-4Amoxicillin40 in 1 BOTTLECAPSULE405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8209-2EA - Each68788-8209fee6fdcd-616d-4e21-bf9c-2cb21645523312022-09-12
68788-8209-3EA - Each68788-82091cba9efb-ae2c-43b5-a666-1f9c5f49daed12022-09-12
68788-8209-4EA - Each68788-820910b784ea-a6d1-4ecd-85cd-3f7c516d229f12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8209AMOXICILLIN CAPSULE [PREFERRED PHAMRACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250205_47424822-14a1-48e0-a62d-df34fe685726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN47424822-14a1-48e0-a62d-df34fe6857265
308191amoxicillin 500 MG Oral CapsuleSCD47424822-14a1-48e0-a62d-df34fe6857265
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY47424822-14a1-48e0-a62d-df34fe6857265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8209-26878882090221 CAPSULE in 1 BOTTLE (68788-8209-2) 21 capsule2022-09-080000-00-00NoNoCurrent
68788-8209-36878882090330 CAPSULE in 1 BOTTLE (68788-8209-3) 30 capsule2022-09-080000-00-00NoNoCurrent
68788-8209-46878882090440 CAPSULE in 1 BOTTLE (68788-8209-4) 40 capsule2022-09-080000-00-00NoNoCurrent