Azithromycin

Product NDC: 50436-0787
11-digit product format: 504360787
Labeler code: 50436
Product ID: 50436-0787_277f2a3d-85c4-4d4b-bbb5-f3003d812b22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
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: 2019-12-31
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
50436-0787-1	2020-01-31	C162847	48780-1	9d75b9d1-1d5e-f424-e053-dadaa90a57ce	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0787-1	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
50436-0787	AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20171130_c6c94568-1e3c-494a-893b-e84f019cc5fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308460	azithromycin 250 MG Oral Tablet	PSN	c6c94568-1e3c-494a-893b-e84f019cc5fc	2
308460	azithromycin 250 MG Oral Tablet	SCD	c6c94568-1e3c-494a-893b-e84f019cc5fc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0787-1	50436078701	6 in 1 BLISTER PACK	Historical