Clarithromycin

Product NDC
60687-435
11-digit product format
606870435
Labeler code
60687
Product ID
60687-435_4d637d2c-35fc-3c3b-e063-6394a90a5772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203584
Marketing category
ANDA
Marketing start
2020-01-29
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
60687-435-11Clarithromycin1 in 1 BLISTER PACKTABLET, FILM COATED16
60687-435-21Clarithromycin30 in 1 BOX, UNIT-DOSETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-435CLARITHROMYCIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20250104_59ebe6cb-c830-45c7-8242-52f9f42a90a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN59ebe6cb-c830-45c7-8242-52f9f42a90a06
197517clarithromycin 500 MG Oral TabletSCD59ebe6cb-c830-45c7-8242-52f9f42a90a06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-435-11606870435111 in 1 BLISTER PACKHistorical
60687-435-216068704352130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-435-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-435-11) 30 blister pack2020-01-292027-06-30NoNoCurrent