FDA.reportPublic FDA data

Clarithromycin

Product NDC
63187-376
11-digit product format
631870376
Labeler code
63187
Product ID
63187-376_f6ee6e86-2078-4354-9def-3f94fc7b6a6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203584
Marketing category
ANDA
Marketing start
2015-12-04
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
63187-376-14Clarithromycin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED146
63187-376-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED206
63187-376-28Clarithromycin28 in 1 BOTTLE, PLASTICTABLET, FILM COATED286
63187-376-30Clarithromycin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
63187-376-60Clarithromycin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606
63187-376-90Clarithromycin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-376CLARITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 6 package rows20220710_9eb306e0-ccfb-418c-82ca-204f20a788f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN9eb306e0-ccfb-418c-82ca-204f20a788f76
197517clarithromycin 500 MG Oral TabletSCD9eb306e0-ccfb-418c-82ca-204f20a788f76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-376-146318703761414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-14) 2025-11-07NoNoCurrent
63187-376-206318703762020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-20) 2021-12-290000-00-00NoNoCurrent
63187-376-286318703762828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-28) 2016-09-010000-00-00NoNoCurrent
63187-376-306318703763030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-30) 2016-09-010000-00-00NoNoCurrent
63187-376-606318703766060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-60) 2016-09-010000-00-00NoNoCurrent
63187-376-906318703769090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-90) 2021-12-290000-00-00NoNoCurrent