Azithromycin

Product NDC
68071-2672
11-digit product format
680712672
Labeler code
68071
Product ID
68071-2672_dc8e486e-619e-4ee1-e053-2a95a90a7940
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
68071-2672-2680712672022 TABLET, FILM COATED in 1 BOTTLE (68071-2672-2) 2022-04-130000-00-00NoNoCurrent
68071-2672-4680712672044 TABLET, FILM COATED in 1 BOTTLE (68071-2672-4) 2022-04-130000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AzithromycinNuCare Pharmaceuticals,Inc.2022-04-13HUMAN PRESCRIPTION DRUG LABEL1