Azithromycin dihydrate

Product NDC
51224-222
11-digit product format
512240222
Labeler code
51224
Product ID
51224-222_568a062a-f21b-4c4b-b5ce-db21cc443231
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA207566
Marketing category
ANDA
Marketing start
2019-07-01
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
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
51224-222-30EA - Each51224-22218440c73-f21f-4e36-a58d-729726cf243312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-222AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [TAGI PHARMA, INC.]4Legacy NDC20250312_df5abe91-2866-4b1a-97f1-4c61fee8f01f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51224-222-305122402223030 TABLET, FILM COATED in 1 BOTTLE (51224-222-30) 2019-07-010000-00-00NoNoCurrent