azithromycin

Product NDC: 76413-149
11-digit product format: 764130149
Labeler code: 76413
Product ID: 76413-149_493ed0fb-c5df-4f14-9155-ce83e903e6cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Central Texas Community Health Centers
Application: NDA050710
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1995-10-19
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 1200 mg/30mL
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
76413-149-30	2020-01-31	C162847	48780-1	9d75b9d0-b854-f424-e053-dadaa90a57ce	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 and Oral Suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76413-149-30	azithromycin	30 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SUSPENSION	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76413-149	AZITHROMYCIN POWDER, FOR SUSPENSION [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]	1	Legacy NDC, 1 package rows	20170830_cccd0bf7-bb87-4586-85b4-4bd622daeba7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN	cccd0bf7-bb87-4586-85b4-4bd622daeba7	1
141963	azithromycin 40 MG/ML Oral Suspension	SCD	cccd0bf7-bb87-4586-85b4-4bd622daeba7	1
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	cccd0bf7-bb87-4586-85b4-4bd622daeba7	1
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	cccd0bf7-bb87-4586-85b4-4bd622daeba7	1
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	cccd0bf7-bb87-4586-85b4-4bd622daeba7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76413-149-30	76413014930	30 mL in 1 BOTTLE, PLASTIC	30 ml	Historical