FDA.reportPublic FDA data

Amoxicillin

Product NDC
68788-8325
11-digit product format
687888325
Labeler code
68788
Product ID
68788-8325_a45cbf04-93b6-4cbb-b029-25e95cf59852
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065334
Marketing category
ANDA
Marketing start
2023-01-19
Substance
AMOXICILLIN
Active strength
400 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
AMOXICILLIN400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308189, 313850

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
68788-8325-1Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8325-1ML - Milliliter68788-83257fa5185c-41f7-4039-87b0-f7b90568712512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8325AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 1 package rows20250205_573fcf4a-2b87-45d9-ac73-e1dec4fbc28b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 40 MG/ML Oral SuspensionSCD573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 80 MG/ML Oral SuspensionSCD573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8325-168788832501100 mL in 1 BOTTLE (68788-8325-1) 100 ml2023-01-19NoNoHistorical