Azithromycin

Product NDC
68071-1528
11-digit product format
680711528
Labeler code
68071
Product ID
68071-1528_bb11fbb5-a55a-2e92-e053-2995a90ac57c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-17
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-1528-5ML - Milliliter68071-15281392216e-d2ab-4d95-913e-c60b56a90cba12017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1528-56807115280515 mL in 1 BOTTLE (68071-1528-5) 15 ml2017-07-180000-00-00NoNoCurrent