azithromycin monohydrate

Product NDC
71205-119
11-digit product format
712050119
Labeler code
71205
Product ID
71205-119_7f9fddc6-bdba-40a3-8eb0-7d1cd7d9a50f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin monohydrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065398
Marketing category
ANDA
Marketing start
2015-08-18
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-119-04EA - Each71205-1192ec821d1-5f93-4963-a6c5-f04265acb75412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-119AZITHROMYCIN MONOHYDRATE TABLET [PROFICIENT RX LP]4Legacy NDC20200229_f6d4eb0c-f530-48da-8af0-7ed4a19619d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-119-03712050119033 TABLET in 1 BOTTLE (71205-119-03) 3 tablet2018-09-040000-00-00NoNoCurrent
71205-119-04712050119044 TABLET in 1 BOTTLE (71205-119-04) 4 tablet2018-09-040000-00-00NoNoCurrent
71205-119-06712050119066 TABLET in 1 BOTTLE (71205-119-06) 6 tablet2018-09-040000-00-00NoNoCurrent