Amoxil

Product NDC
72189-385
11-digit product format
721890385
Labeler code
72189
Product ID
72189-385_2c4cbe6c-c27d-15fe-e063-6294a90ac409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin Oral Susp
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
DirectRx
Application
ANDA065325
Marketing category
ANDA
Marketing start
2022-10-21
Substance
AMOXICILLIN
Active strength
400 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
Amoxil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU

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
72189-385-32Amoxil100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-385AMOXIL (AMOXICILLIN ORAL SUSP) POWDER, FOR SUSPENSION [DIRECTRX]3Current NDC, Legacy NDC, 1 package rows20250123_ec7dd735-dc92-3d29-e053-2a95a90af549.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-385-3272189038532100 mL in 1 BOTTLE (72189-385-32) 100 ml2022-10-210000-00-00NoNoCurrent