Clarithromycin

Product NDC
0904-6872
11-digit product format
009046872
Labeler code
0904
Product ID
0904-6872_d4f040b6-4684-4131-931e-8d8272fadaee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
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
0904-6872-04Clarithromycin1 in 1 BLISTER PACKTABLET, FILM COATED15
0904-6872-04Clarithromycin30 in 1 CARTONTABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6872-04EA - Each0904-6872c0e761d3-f139-475f-b359-029b6f71531a12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6872CLARITHROMYCIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250313_d0a66646-6774-4fc6-9b26-a98c3a5df274.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNd0a66646-6774-4fc6-9b26-a98c3a5df2745
197517clarithromycin 500 MG Oral TabletSCDd0a66646-6774-4fc6-9b26-a98c3a5df2745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6872-040090468720430 BLISTER PACK in 1 CARTON (0904-6872-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2012-07-250000-00-00NoNoCurrent