azithromycin monohydrate

Product NDC
70518-0736
11-digit product format
705180736
Labeler code
70518
Product ID
70518-0736_bfc8834e-1df9-170b-e053-2995a90a28f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin monohydrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065398
Marketing category
ANDA
Marketing start
2017-09-14
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0736-0705180736004 TABLET in 1 BOTTLE, PLASTIC (70518-0736-0) 4 tablet2017-09-140000-00-00NoNoCurrent
70518-0736-17051807360130 TABLET in 1 BLISTER PACK (70518-0736-1) 30 tablet2018-01-220000-00-00NoNoCurrent