clarithromycin

Product NDC
66336-429
11-digit product format
663360429
Labeler code
66336
Product ID
66336-429_5afb5523-36b4-4def-af52-36cc92d187a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA065145
Marketing category
ANDA
Marketing start
2008-01-01
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
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
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-429-202019-11-13C16284748780-197449f38-cd04-f6ea-e053-dbdaa90aa703CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-429-20clarithromycin20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
SODIUM PHOSPHATE, MONOBASIC ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUCLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-429CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20120313_d9db2fd3-a668-4d37-9082-18f6ceb8c3cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359385clarithromycin 500 MG 24HR Extended Release Oral TabletPSNd9db2fd3-a668-4d37-9082-18f6ceb8c3cb1
35938524 HR clarithromycin 500 MG Extended Release Oral TabletSCDd9db2fd3-a668-4d37-9082-18f6ceb8c3cb1
359385clarithromycin 500 MG 24 HR Extended Release Oral TabletSYd9db2fd3-a668-4d37-9082-18f6ceb8c3cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-429-206633604292020 in 1 BOTTLEHistorical