FDA.reportPublic FDA data

Amoxicillin

Product NDC
67296-0220
11-digit product format
672960220
Labeler code
67296
Product ID
67296-0220_e8c2f6fc-ccc4-47c8-9091-0a9ee553ef22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-11-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0220-52019-10-29C16284748780-1960f7f55-c27b-8e05-e053-dbdaa90a074aAmoxicillin Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0220-5Amoxicillin40 in 1 BOTTLECAPSULE402

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0220AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]2Legacy NDC, 1 package rows20110726_6dcd320a-2ba4-4dad-8173-1cef72b4c816.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN6dcd320a-2ba4-4dad-8173-1cef72b4c8162
308191amoxicillin 500 MG Oral CapsuleSCD6dcd320a-2ba4-4dad-8173-1cef72b4c8162
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY6dcd320a-2ba4-4dad-8173-1cef72b4c8162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0220-56729602200540 in 1 BOTTLEHistorical