FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
68071-2775
11-digit product format
680712775
Labeler code
68071
Product ID
68071-2775_e845be92-8263-2844-e053-2a95a90aac3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmceuticals,Inc.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2019-07-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2775-22025-01-30C16284748780-12cef2736-a875-d83d-e063-dadaa90ab31fThese 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
68071-2775-62025-01-30C16284748780-12cef2736-a875-d83d-e063-dadaa90ab31fThese 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
68071-2775-2Azithromycin Dihydrate2 in 1 BOTTLETABLET, FILM COATED22
68071-2775-6Azithromycin Dihydrate6 in 1 BOTTLETABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2775AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [NUCARE PHARMCEUTICALS,INC.]2Legacy NDC, 2 package rows20220911_e2ad6eff-97ff-135a-e053-2a95a90afed5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNe2ad6eff-97ff-135a-e053-2a95a90afed52
248656azithromycin 500 MG Oral TabletSCDe2ad6eff-97ff-135a-e053-2a95a90afed52
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYe2ad6eff-97ff-135a-e053-2a95a90afed52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2775-2680712775022 TABLET, FILM COATED in 1 BOTTLE (68071-2775-2) 2022-06-300000-00-00NoNoCurrent
68071-2775-6680712775066 TABLET, FILM COATED in 1 BOTTLE (68071-2775-6) 2022-06-300000-00-00NoNoCurrent