clarithromycin

Product NDC
43063-520
11-digit product format
430630520
Labeler code
43063
Product ID
43063-520_cb078678-716c-b494-e053-2a95a90a9d60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065145
Marketing category
ANDA
Marketing start
2014-02-27
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-520-14EA - Each43063-5207578af5a-3ae8-440a-b984-22cc5df7366f12014-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-520-144306305201414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-520-14) 2018-01-010000-00-00NoNoCurrent