azithromycin monohydrate

Product NDC: 50436-3136
11-digit product format: 504363136
Labeler code: 50436
Product ID: 50436-3136_fd611572-856d-4d95-8c5b-2b2bf2ed1317
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin monohydrate
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA065399
Marketing category: ANDA
Marketing start: 2015-08-18
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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
50436-3136-3	2021-01-29	C162847	48780-1	ba0f9c33-4b29-a910-e053-dadaa90a0b85	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, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991
50436-3136-4	2021-01-29	C162847	48780-1	ba0f9c33-4b29-a910-e053-dadaa90a0b85	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, 250 mg and 500 mg, 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
50436-3136-3	azithromycin monohydrate	2 in 1 BOTTLE	TABLET	2		2
50436-3136-4	azithromycin monohydrate	1 in 1 BOTTLE	TABLET	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3136	AZITHROMYCIN MONOHYDRATE TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 2 package rows	20170816_764193ca-7fdd-4e3b-aa52-cc8777936fba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
248656	azithromycin 500 MG Oral Tablet	PSN	764193ca-7fdd-4e3b-aa52-cc8777936fba	2
248656	azithromycin 500 MG Oral Tablet	SCD	764193ca-7fdd-4e3b-aa52-cc8777936fba	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	764193ca-7fdd-4e3b-aa52-cc8777936fba	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-3136-3	50436313603	2 in 1 BOTTLE	Historical
50436-3136-4	50436313604	1 in 1 BOTTLE	Historical