Azithromycin

Product NDC
70518-3508
11-digit product format
705183508
Labeler code
70518
Product ID
70518-3508_e818a6d6-0a91-c84f-e053-2995a90ae5cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207398
Marketing category
ANDA
Marketing start
2022-09-05
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3508AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]4Legacy NDC20241108_12e39d3d-de16-4735-8897-cbf82148a3f5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3508-0705183508002 POUCH in 1 BOX (70518-3508-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3508-1) 2 pouch2022-09-050000-00-00NoNoCurrent