Amoxicillin

Product NDC
67296-0628
11-digit product format
672960628
Labeler code
67296
Product ID
67296-0628_a11bffa2-a62e-467f-819c-bbabe82bb568
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA065255
Marketing category
ANDA
Marketing start
2006-03-29
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
67296-0628-12019-10-29C16284748780-1960f7f55-cac7-8e05-e053-dbdaa90a074aAMOXICILLIN TABLETS, USP 875 mg Rx only Revised: August 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0628-1Amoxicillin20 in 1 BOTTLETABLET, COATED202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0628AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2Legacy NDC, 1 package rows20110706_01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa2
308194amoxicillin 875 MG Oral TabletSCD01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0628-16729606280120 in 1 BOTTLEHistorical