FDA.reportPublic FDA data

Azithromycin

Product NDC
68071-5082
11-digit product format
680715082
Labeler code
68071
Product ID
68071-5082_4656df2a-41f4-9b9a-e063-6294a90a0b4d
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
68071-5082-62024-06-19C16284748780-1ba0f9c33-1f0d-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
68071-5082-62023-01-30C16284748780-1ba0f9c33-1f0d-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
68071-5082-62021-02-19C16284748780-1ba0f9c33-1f0d-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
68071-5082-62021-01-29C16284748780-1ba0f9c33-1f0d-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
68071-5082-5Azithromycin5 in 1 BOTTLETABLET, FILM COATED55
68071-5082-6Azithromycin6 in 1 BOTTLETABLET, FILM COATED65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5082AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20241124_94e17ae5-0871-67a0-e053-2995a90ae0ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN94e17ae5-0871-67a0-e053-2995a90ae0ae5
248656azithromycin 500 MG Oral TabletSCD94e17ae5-0871-67a0-e053-2995a90ae0ae5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY94e17ae5-0871-67a0-e053-2995a90ae0ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5082-5680715082055 TABLET, FILM COATED in 1 BOTTLE (68071-5082-5) 2025-12-19NoNoCurrent
68071-5082-6680715082066 TABLET, FILM COATED in 1 BOTTLE (68071-5082-6) 2019-10-140000-00-00NoNoCurrent