Azithromycin dihydrate

Product NDC
70518-3249
11-digit product format
705183249
Labeler code
70518
Product ID
70518-3249_ea36938c-8555-678d-e053-2a95a90a0ee5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207566
Marketing category
ANDA
Marketing start
2021-10-18
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
600 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
70518-3249AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.]4Legacy NDC20240316_c1f4febb-2ff0-4ecd-93fc-fd049664807d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3249-07051832490030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3249-0) 2021-10-180000-00-00NoNoCurrent