Azithromycin

Product NDC
71610-001
11-digit product format
716100001
Labeler code
71610
Product ID
71610-001_888edaa1-a8bd-43da-aa09-6eb5ee7fe515
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA065211
Marketing category
ANDA
Marketing start
2017-03-02
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-001-06EA - Each71610-001605f680a-af9c-428f-bff0-882ea2a8254112018-02-20
71610-001-30EA - Each71610-00103af7097-1654-48c8-81f4-f61e6c2ffb6012018-02-20
71610-001-87EA - Each71610-001fe8043e6-c635-4224-a635-3e6c6428313812018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-001AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Legacy NDC20190301_ec761c30-18cf-49b1-a444-69cd28a9b960.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-001-06716100001066 TABLET, FILM COATED in 1 BOTTLE (71610-001-06) 2017-07-310000-00-00NoNoCurrent
71610-001-307161000013030 TABLET, FILM COATED in 1 BOTTLE (71610-001-30) 2017-07-310000-00-00NoNoCurrent
71610-001-87716100001872400 TABLET, FILM COATED in 1 BOTTLE (71610-001-87) 2017-08-230000-00-00NoNoCurrent