FDA.reportPublic FDA data

Azithromycin

Product NDC
68071-5058
11-digit product format
680715058
Labeler code
68071
Product ID
68071-5058_1b4318a7-a74c-c7bc-e063-6394a90aeafb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656

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
68071-5058-32024-06-19C16284748780-1ba0f9c33-5b5c-a910-e053-dadaa90a0b85These 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
68071-5058-32023-01-30C16284748780-1ba0f9c33-5b5c-a910-e053-dadaa90a0b85These 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
68071-5058-32021-02-19C16284748780-1ba0f9c33-5b5c-a910-e053-dadaa90a0b85These 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
68071-5058-32021-01-29C16284748780-1ba0f9c33-5b5c-a910-e053-dadaa90a0b85These 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 NDCProductDescriptionFormQuantityStrengthSPL version
68071-5058-3Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5058AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240620_9270e676-3382-6483-e053-2a95a90a556e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN9270e676-3382-6483-e053-2a95a90a556e3
248656azithromycin 500 MG Oral TabletSCD9270e676-3382-6483-e053-2a95a90a556e3
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY9270e676-3382-6483-e053-2a95a90a556e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5058-3680715058033 TABLET, FILM COATED in 1 BLISTER PACK (68071-5058-3) 2019-09-130000-00-00NoNoCurrent