azithromycin

Product NDC: 68071-2543
11-digit product format: 680712543
Labeler code: 68071
Product ID: 68071-2543_cd01f368-6c44-1ef0-e053-2a95a90a5734
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: NDA050711
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-05-13
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: 2022-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2543-6	2025-01-30	C162847	48780-1	f386c649-9fe4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
68071-2543-6	2023-07-17	C162847	48780-1	f386c649-9fe4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
68071-2543-6	2023-01-30	C162847	48780-1	f386c649-9fe4-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2543-6	azithromycin	6 in 1 BLISTER PACK	TABLET, FILM COATED	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2543	AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 1 package rows	20230718_cd01f37d-4392-4d2b-e053-2995a90a721f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	cd01f37d-4392-4d2b-e053-2995a90a721f	2
308460	azithromycin 250 MG Oral Tablet	PSN	cd01f37d-4392-4d2b-e053-2995a90a721f	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	cd01f37d-4392-4d2b-e053-2995a90a721f	2
308460	azithromycin 250 MG Oral Tablet	SCD	cd01f37d-4392-4d2b-e053-2995a90a721f	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	cd01f37d-4392-4d2b-e053-2995a90a721f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2543-6	68071254306	6 TABLET, FILM COATED in 1 BLISTER PACK (68071-2543-6)	2021-09-27	0000-00-00	No	No	Current