Amoxicillin

Product NDC
68788-7323
11-digit product format
687887323
Labeler code
68788
Product ID
68788-7323_0aaa8a08-10ea-4b03-8734-13518addef54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065325
Marketing category
ANDA
Marketing start
2006-06-19
Substance
AMOXICILLIN
Active strength
200 mg/5mL
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
AMOXICILLIN200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui313850

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
68788-7323-1Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7323-1ML - Milliliter68788-732356b5a47c-7d40-4af5-8c31-5baeaf7ce33112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7323AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 1 package rows20250112_afef7c71-2d19-41ed-9213-b32ccc1bf1d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSNafef7c71-2d19-41ed-9213-b32ccc1bf1d38
313850amoxicillin 40 MG/ML Oral SuspensionSCDafef7c71-2d19-41ed-9213-b32ccc1bf1d38
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSYafef7c71-2d19-41ed-9213-b32ccc1bf1d38
313850amoxicillin 200 MG per 5 ML Oral SuspensionSYafef7c71-2d19-41ed-9213-b32ccc1bf1d38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7323-168788732301100 mL in 1 BOTTLE (68788-7323-1) 100 ml2019-03-120000-00-00NoNoCurrent