FDA.reportPublic FDA data

Clarithromycin

Product NDC
82804-069
11-digit product format
828040069
Labeler code
82804
Product ID
82804-069_28f60574-4ecd-441c-aebe-5b1d18033ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065136
Marketing category
ANDA
Marketing start
2005-08-25
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
82804-069-20Clarithromycin20 in 1 BOTTLETABLET201
82804-069-30Clarithromycin30 in 1 BOTTLETABLET301
82804-069-60Clarithromycin60 in 1 BOTTLETABLET601
82804-069-90Clarithromycin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-069-20EA - Each82804-069d0ca5a95-e656-4caa-8358-4e5514923fb212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-069CLARITHROMYCIN TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20240208_28f60574-4ecd-441c-aebe-5b1d18033ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN28f60574-4ecd-441c-aebe-5b1d18033ef61
197517clarithromycin 500 MG Oral TabletSCD28f60574-4ecd-441c-aebe-5b1d18033ef61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-069-208280400692020 TABLET in 1 BOTTLE (82804-069-20) 20 tablet2024-02-01NoNoCurrent
82804-069-308280400693030 TABLET in 1 BOTTLE (82804-069-30) 30 tablet2024-02-01NoNoCurrent
82804-069-608280400696060 TABLET in 1 BOTTLE (82804-069-60) 60 tablet2024-02-01NoNoCurrent
82804-069-908280400699090 TABLET in 1 BOTTLE (82804-069-90) 90 tablet2024-02-01NoNoCurrent