Clarithromycin

Product NDC
64679-949
11-digit product format
646790949
Labeler code
64679
Product ID
64679-949_ca177dbb-f30f-466a-b9c3-a0fe80c7887a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA065266
Marketing category
ANDA
Marketing start
2006-05-31
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-949-01EA - Each64679-949de0ef71d-322a-40f4-8e44-3de6c7a0a2e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSNb333961e-22af-41de-9fad-192d56af8d381
197517clarithromycin 500 MG Oral TabletPSN144e4973-d24a-4003-b5b1-d59fd835d8841
197517clarithromycin 500 MG Oral TabletPSN4452ba66-1d7a-4253-a278-b7775887e6d81
197517clarithromycin 500 MG Oral TabletPSNb333961e-22af-41de-9fad-192d56af8d381
197516clarithromycin 250 MG Oral TabletSCDb333961e-22af-41de-9fad-192d56af8d381
197517clarithromycin 500 MG Oral TabletSCD144e4973-d24a-4003-b5b1-d59fd835d8841
197517clarithromycin 500 MG Oral TabletSCD4452ba66-1d7a-4253-a278-b7775887e6d81
197517clarithromycin 500 MG Oral TabletSCDb333961e-22af-41de-9fad-192d56af8d381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-949-016467909490160 TABLET, FILM COATED in 1 BOTTLE (64679-949-01) 2006-05-310000-00-00NoNoCurrent
64679-949-02646790949021200 TABLET, FILM COATED in 1 POUCH (64679-949-02) 2006-05-310000-00-00NoNoCurrent