Azithromycin

Product NDC
68071-2905
11-digit product format
680712905
Labeler code
68071
Product ID
68071-2905_f05c3c9f-06a5-7efb-e053-2995a90a4a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207370
Marketing category
ANDA
Marketing start
2018-07-05
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5FD1131I7SAZITHROMYCIN DIHYDRATE117772-70-0AZITHROMYCIN DIHYDRATE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2905-26807129050212 TABLET, FILM COATED in 1 BOTTLE (68071-2905-2) 2022-12-210000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AzithromycinNuCare Pharmaceuticals,Inc.2022-12-21HUMAN PRESCRIPTION DRUG LABEL1