FDA.reportPublic FDA data

Amoxicillin

Product NDC
67296-0023
11-digit product format
672960023
Labeler code
67296
Product ID
67296-0023_1d333c09-ee5d-4d2a-bf1e-a68b939794f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
2010-01-28
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
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
67296-0023-12019-10-29C16284748780-1960f7f55-cefc-8e05-e053-dbdaa90a074aAMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg 3107 3109 2267 2268 4150 4155 Rx only
67296-0023-22019-10-29C16284748780-1960f7f55-cefc-8e05-e053-dbdaa90a074aAMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg 3107 3109 2267 2268 4150 4155 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0023-1Amoxicillin30 in 1 BOTTLECAPSULE3010
67296-0023-2Amoxicillin40 in 1 BOTTLECAPSULE4010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0023AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10Legacy NDC, 2 package rows20110808_f1bf6b2f-d00a-4c3c-a55c-46bb0ad6d5c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0023-16729600230130 in 1 BOTTLEHistorical
67296-0023-26729600230240 in 1 BOTTLEHistorical