azithromycin

Product NDC
70518-3094
11-digit product format
705183094
Labeler code
70518
Product ID
70518-3094_d0fe1360-a324-6a16-e053-2995a90a05c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209044
Marketing category
ANDA
Marketing start
2021-05-13
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3094-02023-03-16C16284748780-1f386c649-e684-0266-e053-dadaa90a7c1a89a8e05f-b60c-4b8f-96c4-d49222163fbc
70518-3094-02023-01-30C16284748780-1f386c649-e684-0266-e053-dadaa90a7c1a89a8e05f-b60c-4b8f-96c4-d49222163fbc

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3094AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.]6Legacy NDC20240927_89a8e05f-b60c-4b8f-96c4-d49222163fbc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3094-0705183094002 POUCH in 1 BOX (70518-3094-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3094-1) 2 pouch2021-05-130000-00-00NoNoCurrent