FDA.reportPublic FDA data

Clarithromycin

Product NDC
72189-299
11-digit product format
721890299
Labeler code
72189
Product ID
72189-299_2c2941fa-11d7-9f72-e063-6394a90af886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA065136
Marketing category
ANDA
Marketing start
2021-12-02
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLARITHROMYCIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui197517

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-299-10Clarithromycin10 in 1 BOTTLETABLET104
72189-299-20Clarithromycin20 in 1 BOTTLETABLET204
72189-299-28Clarithromycin28 in 1 BOTTLETABLET284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-299-10EA - Each72189-29955281ab9-7fc0-4470-a798-726418e1dc9912024-01-04
72189-299-20EA - Each72189-29948d07c3a-95ed-472a-9f88-15d9d14105e712022-01-06
72189-299-28EA - Each72189-2992bb0e014-ece5-4e93-83df-68632fd85c0512022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-299CLARITHROMYCIN TABLET [DIRECTRX]4Current NDC, Legacy NDC, 3 package rows20250121_d22bd12c-737b-4aab-e053-2995a90aff60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNd22bd12c-737b-4aab-e053-2995a90aff604
197517clarithromycin 500 MG Oral TabletSCDd22bd12c-737b-4aab-e053-2995a90aff604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-299-107218902991010 TABLET in 1 BOTTLE (72189-299-10) 10 tablet2021-12-02NoNoCurrent
72189-299-207218902992020 TABLET in 1 BOTTLE (72189-299-20) 20 tablet2021-12-020000-00-00NoNoCurrent
72189-299-287218902992828 TABLET in 1 BOTTLE (72189-299-28) 28 tablet2021-12-020000-00-00NoNoCurrent