azithromycin

Product NDC
48792-7871
11-digit product format
487927871
Labeler code
48792
Product ID
48792-7871_7d6b50cc-0b70-443d-e053-2991aa0ac583
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA209043
Marketing category
ANDA
Marketing start
2018-12-20
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
600 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7871-14879278710130 TABLET, FILM COATED in 1 BOTTLE (48792-7871-1) 2018-12-200000-00-00NoNoCurrent