FDA.reportPublic FDA data

Clarithromycin

Product NDC
63187-625
11-digit product format
631870625
Labeler code
63187
Product ID
63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065489
Marketing category
ANDA
Marketing start
2012-07-25
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
63187-625-14Clarithromycin14 in 1 BOTTLETABLET, FILM COATED143
63187-625-28Clarithromycin28 in 1 BOTTLETABLET, FILM COATED283
63187-625-30Clarithromycin60 in 1 BOTTLETABLET, FILM COATED603
63187-625-60Clarithromycin30 in 1 BOTTLETABLET, FILM COATED303
63187-625-90Clarithromycin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-625CLARITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20210113_b1bdf526-4f16-4130-b614-4cb678f060d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNb1bdf526-4f16-4130-b614-4cb678f060d73
197517clarithromycin 500 MG Oral TabletSCDb1bdf526-4f16-4130-b614-4cb678f060d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-625-146318706251414 TABLET, FILM COATED in 1 BOTTLE (63187-625-14) 2018-12-010000-00-00NoNoCurrent
63187-625-286318706252828 TABLET, FILM COATED in 1 BOTTLE (63187-625-28) 2018-12-010000-00-00NoNoCurrent
63187-625-306318706253060 TABLET, FILM COATED in 1 BOTTLE (63187-625-30) 2018-12-010000-00-00NoNoCurrent
63187-625-606318706256030 TABLET, FILM COATED in 1 BOTTLE (63187-625-60) 2018-12-010000-00-00NoNoCurrent
63187-625-906318706259090 TABLET, FILM COATED in 1 BOTTLE (63187-625-90) 2018-12-010000-00-00NoNoCurrent