FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
67296-1914
11-digit product format
672961914
Labeler code
67296
Product ID
67296-1914_3251e4b2-f17c-f99f-e063-6394a90a6af9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA062216
Marketing category
ANDA
Marketing start
2022-09-15
Substance
AMOXICILLIN
Active strength
500 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
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
67296-1914-3AMOXICILLIN30 in 1 BOTTLECAPSULE304
67296-1914-4AMOXICILLIN40 in 1 BOTTLECAPSULE404
67296-1914-6AMOXICILLIN60 in 1 BOTTLECAPSULE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1914AMOXICILLIN CAPSULE [REDPHARM DRUG]4Current NDC, 3 package rows20250410_0a100e76-513c-98d3-e063-6294a90adf47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN0a100e76-513c-98d3-e063-6294a90adf474
308191amoxicillin 500 MG Oral CapsuleSCD0a100e76-513c-98d3-e063-6294a90adf474
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY0a100e76-513c-98d3-e063-6294a90adf474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1914-36729619140330 CAPSULE in 1 BOTTLE (67296-1914-3) 30 capsule2022-09-15NoNoCurrent
67296-1914-46729619140440 CAPSULE in 1 BOTTLE (67296-1914-4) 40 capsule2022-09-15NoNoCurrent
67296-1914-66729619140660 CAPSULE in 1 BOTTLE (67296-1914-6) 60 capsule2022-09-15NoNoCurrent