Azithromycin

Product NDC
68071-5238
11-digit product format
680715238
Labeler code
68071
Product ID
68071-5238_d772bc4a-2d38-c724-e053-2a95a90a111f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210000
Marketing category
ANDA
Marketing start
2019-03-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5238-62022-02-07C16284748780-1d6a99b39-88a9-a426-e053-dadaa90af4c2a2cb5c58-d5f4-b168-e053-2a95a90ab5f7
68071-5238-62022-01-28C16284748780-1d6a99b39-88a9-a426-e053-dadaa90af4c2a2cb5c58-d5f4-b168-e053-2a95a90ab5f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5238-6680715238066 TABLET, FILM COATED in 1 BOX (68071-5238-6) 2020-04-080000-00-00NoNoCurrent