Azithromycin

Product NDC
68071-2507
11-digit product format
680712507
Labeler code
68071
Product ID
68071-2507_c9ffa335-c61e-2692-e053-2995a90abd1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210001
Marketing category
ANDA
Marketing start
2019-03-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 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
68071-2507-32023-01-30C16284748780-1f386c649-a0cd-0266-e053-dadaa90a7c1ac9ffa335-c61d-2692-e053-2995a90abd1a

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2507AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210822_c9ffa335-c61d-2692-e053-2995a90abd1a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2507-3680712507031 BLISTER PACK in 1 CARTON (68071-2507-3) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-08-200000-00-00NoNoCurrent