FDA.reportPublic FDA data

Clarithromycin

Product NDC
0054-0037
11-digit product format
000540037
Labeler code
0054
Product ID
0054-0037_4fa22138-ea75-4959-96c8-b432b2162c0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clarithromycin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA065178
Marketing category
ANDA
Marketing start
2004-05-25
Marketing end
2020-07-05
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0037-21EA - Each0054-0037994a474c-480a-480d-bf8e-ee7cf676449212012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNaf99089d-90c6-4a36-8edb-8da0a09f1b2a1
197517clarithromycin 500 MG Oral TabletSCDaf99089d-90c6-4a36-8edb-8da0a09f1b2a1