FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
52959-838
11-digit product format
529590838
Labeler code
52959
Product ID
52959-838_004b13ef-8ffb-434a-9abd-18085b6a0793
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065404
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-838-062019-11-13C16284748780-197449f38-b981-f6ea-e053-dbdaa90aa7036307a49b-753a-4232-a51d-bf6d0537b05b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-838-06AZITHROMYCIN6 in 1 CARTONTABLET, FILM COATED62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-838-06EA - Each52959-838d7754ed6-80e1-41df-bb06-20695c1362cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-838AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20120217_6307a49b-753a-4232-a51d-bf6d0537b05b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK6307a49b-753a-4232-a51d-bf6d0537b05b2
308460azithromycin 250 MG Oral TabletPSN6307a49b-753a-4232-a51d-bf6d0537b05b2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN6307a49b-753a-4232-a51d-bf6d0537b05b2
308460azithromycin 250 MG Oral TabletSCD6307a49b-753a-4232-a51d-bf6d0537b05b2
749783azithromycin 250 MG Oral Tablet 6 Count PackSY6307a49b-753a-4232-a51d-bf6d0537b05b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-838-06529590838066 in 1 CARTONHistorical