Azithromycin

Product NDC: 70518-3169
11-digit product format: 705183169
Labeler code: 70518
Product ID: 70518-3169_c81c0fd9-13da-4307-e053-2995a90a1f07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210001
Marketing category: ANDA
Marketing start: 2021-07-22
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
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3169-0	2023-03-20	C162847	48780-1	f386c649-aa0b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
70518-3169-0	2023-01-30	C162847	48780-1	f386c649-aa0b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3169	AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]	5	Legacy NDC	20240919_309652c7-e8a9-4b10-b88a-8812212f7ad3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3169-0	70518316900	2 TABLET, FILM COATED in 1 BLISTER PACK (70518-3169-0)	2021-07-22	0000-00-00	No	No	Current