Amoxicillin

Product NDC
66336-074
11-digit product format
663360074
Labeler code
66336
Product ID
66336-074_3fe12e39-1a78-4177-b703-cad97bcd26b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dispensing Solutions, 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
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
66336-074-302019-11-27C16284748780-19855d018-df7c-cd31-e053-dbdaa90ab51aAMOXICILLIN TABLETS, USP 875 mg Rx only Revised: August 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-074-30Amoxicillin30 in 1 BOTTLETABLET, COATED303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOLsINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-074AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 1 package rows20121004_74e8883b-1334-4132-a31a-adb1cd05f80b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN74e8883b-1334-4132-a31a-adb1cd05f80b3
308194amoxicillin 875 MG Oral TabletSCD74e8883b-1334-4132-a31a-adb1cd05f80b3
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY74e8883b-1334-4132-a31a-adb1cd05f80b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-074-306633600743030 in 1 BOTTLEHistorical