Azithromycin

Product NDC
50090-5283
11-digit product format
500905283
Labeler code
50090
Product ID
50090-5283_7942d435-d99b-45de-bf0d-9ea2608c2f09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209201
Marketing category
ANDA
Marketing start
2018-10-09
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5283-02023-02-07C16284748780-1f386c649-a72c-0266-e053-dadaa90a7c1a2c9bf77f-050f-4cdd-b5e9-cc64fbbc9671
50090-5283-02023-01-30C16284748780-1f386c649-a72c-0266-e053-dadaa90a7c1a2c9bf77f-050f-4cdd-b5e9-cc64fbbc9671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5283-0500905283001 BOTTLE in 1 CARTON (50090-5283-0) > 15 mL in 1 BOTTLE1 bottle2020-10-220000-00-00NoNoCurrent