Azithromycin

Product NDC
68071-5170
11-digit product format
680715170
Labeler code
68071
Product ID
68071-5170_bbf62556-4321-89dc-e053-2995a90a1251
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
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
68071-5170-32024-06-20C16284748780-1f386c64a-27b3-0266-e053-dadaa90a7c1a9e64ae3b-63c7-5107-e053-2995a90a0164
68071-5170-32023-01-30C16284748780-1f386c64a-27b3-0266-e053-dadaa90a7c1a9e64ae3b-63c7-5107-e053-2995a90a0164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5170-36807151700330 TABLET, FILM COATED in 1 BOTTLE (68071-5170-3) 2020-02-120000-00-00NoNoCurrent