Azithromycin

Product NDC
63187-604
11-digit product format
631870604
Labeler code
63187
Product ID
63187-604_abb13010-cce0-4ca8-8078-134ebf73c49a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065404
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-604-06EA - Each63187-60459f2dc7e-98ec-474a-9918-4d019f6fb2d112016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-604AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20210113_aefc926a-b318-49c3-aa9d-cfe2c4f19597.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-604-06631870604066 TABLET, FILM COATED in 1 BLISTER PACK (63187-604-06) 2018-12-010000-00-00NoNoCurrent