FDA.reportPublic FDA data

Amoxicillin

Product NDC
0440-7100
11-digit product format
004407100
Labeler code
0440
Product ID
0440-7100_9d821181-fd97-4057-8fca-f7dc12ac89ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA062884
Marketing category
ANDA
Marketing start
1988-02-25
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
0440-7100-302020-01-31C16284748780-19d75b9d1-07b9-f424-e053-dadaa90a57ceAMOXICILLIN CAPSULES, USP 250 mg and 500 mg AMOXICILLIN TABLETS, USP 875 mg AMOXICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7100-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7100AMOXICILLIN CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20130909_0fb026d7-065b-4d0c-823b-45ddef8706a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN0fb026d7-065b-4d0c-823b-45ddef8706a71
308182amoxicillin 250 MG Oral CapsuleSCD0fb026d7-065b-4d0c-823b-45ddef8706a71
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY0fb026d7-065b-4d0c-823b-45ddef8706a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7100-300044071003030 in 1 BOTTLE, PLASTICHistorical