FDA.reportPublic FDA data

Clarithromycin

Product NDC
21695-557
11-digit product format
216950557
Labeler code
21695
Product ID
21695-557_f3a50f13-b028-4135-8f20-bfb62a9bc0a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065144
Marketing category
ANDA
Marketing start
2005-10-18
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
250 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
21695-557-102019-09-24C16284748780-1934fe258-4710-48b1-e053-8cdaa90a720aClarithromycin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-557-10Clarithromycin10 in 1 BOTTLETABLET101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-557-10EA - Each21695-557535c1040-d91c-480a-af4c-e572c4d538dc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clarithromycinACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
clarithromycinACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-557CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100921_f3a50f13-b028-4135-8f20-bfb62a9bc0a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSNf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletPSNf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197516clarithromycin 250 MG Oral TabletSCDf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletSCDf3a50f13-b028-4135-8f20-bfb62a9bc0a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-557-102169505571010 in 1 BOTTLEHistorical