Clarithromycin

Product NDC
21695-558
11-digit product format
216950558
Labeler code
21695
Product ID
21695-558_f3a50f13-b028-4135-8f20-bfb62a9bc0a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065136
Marketing category
ANDA
Marketing start
2005-08-25
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-558-10Clarithromycin10 in 1 BOTTLETABLET101
21695-558-14Clarithromycin14 in 1 BOTTLETABLET141
21695-558-20Clarithromycin20 in 1 BOTTLETABLET201
21695-558-28Clarithromycin28 in 1 BOTTLETABLET281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-558-10EA - Each21695-55876faef6b-edd7-4693-b60b-5492196ddd3312012-07-24
21695-558-14EA - Each21695-55858b96e5e-048d-4931-8945-e13f084b30f012012-07-24
21695-558-20EA - Each21695-55891ce61df-321d-4eea-ac39-6389211713ec12012-07-24
21695-558-28EA - Each21695-5586eb1a555-ce9d-403b-b57c-2c42d21984ad12012-07-24

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
21695-558CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 4 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
21695-558-102169505581010 in 1 BOTTLEHistorical
21695-558-142169505581414 in 1 BOTTLEHistorical
21695-558-202169505582020 in 1 BOTTLEHistorical
21695-558-282169505582828 in 1 BOTTLEHistorical