AZITHROMYCIN

Product NDC
55700-784
11-digit product format
557000784
Labeler code
55700
Product ID
55700-784_77f5fb36-a2cf-4fb8-919e-dd2e589cc8da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA207531
Marketing category
ANDA
Marketing start
2019-08-30
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-784-152025-01-10C16284748780-1f386c649-dbf0-0266-e053-dadaa90a7c1a7d1b831c-41ba-4709-b1a7-b316375852de
55700-784-152023-01-30C16284748780-1f386c649-dbf0-0266-e053-dadaa90a7c1a7d1b831c-41ba-4709-b1a7-b316375852de

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-784-15ML - Milliliter55700-784c80808ed-3bad-4abb-9f8e-5adbff1432d612019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-784-155570007841515 mL in 1 BOTTLE, PLASTIC (55700-784-15) 15 ml2019-08-300000-00-00NoNoCurrent