azithromycin monohydrate

Product NDC: 53002-3221
11-digit product format: 530023221
Labeler code: 53002
Product ID: 53002-3221_b77ad349-57b2-4c0c-8c0b-e35338ee628c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin monohydrate
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA065399
Marketing category: ANDA
Marketing start: 2015-08-18
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: 2021-12-31
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
53002-3221-2	2023-01-30	C162847	48780-1	f386c649-a10c-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, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991
53002-3221-5	2023-01-30	C162847	48780-1	f386c649-a10c-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, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991
53002-3221-6	2023-01-30	C162847	48780-1	f386c649-a10c-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, 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
53002-3221-2	azithromycin monohydrate	2 in 1 BOTTLE	TABLET	2		1
53002-3221-5	azithromycin monohydrate	5 in 1 BOTTLE	TABLET	5		1
53002-3221-6	azithromycin monohydrate	6 in 1 BOTTLE	TABLET	6		1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE
JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE	121470-24-4	azithromycin monohydrate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
248656	azithromycin 500 MG Oral Tablet	PSN	4d8a9adc-36f4-4f83-a153-c7979967d316	1
248656	azithromycin 500 MG Oral Tablet	SCD	4d8a9adc-36f4-4f83-a153-c7979967d316	1
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	4d8a9adc-36f4-4f83-a153-c7979967d316	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3221-2	53002322102	2 TABLET in 1 BOTTLE (53002-3221-2)	2 tablet	2019-01-01	0000-00-00	No	No	Current
53002-3221-5	53002322105	5 TABLET in 1 BOTTLE (53002-3221-5)	5 tablet	2019-01-01	0000-00-00	No	No	Current
53002-3221-6	53002322106	6 TABLET in 1 BOTTLE (53002-3221-6)	6 tablet	2019-01-01	0000-00-00	No	No	Current