Clarithromycin

Product NDC
70518-0204
11-digit product format
705180204
Labeler code
70518
Product ID
70518-0204_47e4ef55-557f-9edf-e063-6394a90a4724
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065489
Marketing category
ANDA
Marketing start
2017-02-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2027-12-31

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
70518-0204-0Clarithromycin30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-0204-1Clarithromycin28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0204CLARITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 2 package rows20250425_9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c613
197517clarithromycin 500 MG Oral TabletSCD9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-0204-07051802040030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0204-0) 2017-02-07NoNoHistorical
70518-0204-17051802040128 in 1 BOTTLE, PLASTICHistorical