Azithromycin

Product NDC
68788-8229
11-digit product format
687888229
Labeler code
68788
Product ID
68788-8229_0240ffbf-d022-430c-9e77-84176b49a43f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211147
Marketing category
ANDA
Marketing start
2022-08-08
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
100 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8229-1ML - Milliliter68788-822949143d25-976e-4605-9556-42ddc972c7d912022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8229-1687888229011 BOTTLE in 1 CARTON (68788-8229-1) > 15 mL in 1 BOTTLE1 bottle2022-08-080000-00-00NoNoCurrent