Azithromycin

Product NDC
70518-3217
11-digit product format
705183217
Labeler code
70518
Product ID
70518-3217_cbe2dcf4-b0c4-1f7b-e053-2995a90a9f3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065211
Marketing category
ANDA
Marketing start
2021-09-10
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 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
70518-3217-02023-04-19C16284748780-1f386c64a-13d3-0266-e053-dadaa90a7c1a6629d927-7913-4ef3-a024-686ac1dc8194
70518-3217-02023-01-30C16284748780-1f386c64a-13d3-0266-e053-dadaa90a7c1a6629d927-7913-4ef3-a024-686ac1dc8194

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3217AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]3Legacy NDC20240316_6629d927-7913-4ef3-a024-686ac1dc8194.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3217-0705183217006 DOSE PACK in 1 CARTON (70518-3217-0) > 1 TABLET, FILM COATED in 1 DOSE PACK6 dose pack2021-09-100000-00-00NoNoCurrent