CLARITHROMYCIN

Product NDC
62135-615
11-digit product format
621350615
Labeler code
62135
Product ID
62135-615_f08573c8-02d4-3717-e053-2a95a90a2dda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA065384
Marketing category
ANDA
Marketing start
2007-08-20
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
Rxcui197516, 197517

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
62135-615-60CLARITHROMYCIN60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-615-60EA - Each62135-6159783389e-5d39-42f6-8443-6f565603a39412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-615CLARITHROMYCIN TABLET, FILM COATED [CHARTWELL RX, LLC.]2Current NDC, Legacy NDC, 1 package rows20221224_99d2fd6b-39ca-42f9-ad06-30e7fbc22c47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197517clarithromycin 500 MG Oral TabletPSN99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197516clarithromycin 250 MG Oral TabletSCD99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197517clarithromycin 500 MG Oral TabletSCD99d2fd6b-39ca-42f9-ad06-30e7fbc22c472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-615-606213506156060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-615-60) 2021-02-010000-00-00NoNoCurrent