Azithromycin

Product NDC
68071-1323
11-digit product format
680711323
Labeler code
68071
Product ID
68071-1323_b17e88fa-dc8c-273f-e053-2995a90a5228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065225
Marketing category
ANDA
Marketing start
2006-01-06
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1323-62020-10-12C16284748780-19d75b9d0-0925-f424-e053-dadaa90a57ce57825cb5-9e61-7c48-e053-2a91aa0a3cd7
68071-1323-62020-01-31C16284748780-19d75b9d0-0925-f424-e053-dadaa90a57ce57825cb5-9e61-7c48-e053-2a91aa0a3cd7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-1323-6EA - Each68071-132333a6dd98-6915-4b14-a28b-94e8b06efbf312017-09-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-1323-6680711323066 TABLET, FILM COATED in 1 BOX (68071-1323-6) 2017-08-240000-00-00NoNoCurrent