FDA.reportPublic FDA data

AZITHROMYCIN MONOHYDRATE

Product NDC
61919-170
11-digit product format
619190170
Labeler code
61919
Product ID
61919-170_92c05d6e-133b-b404-e053-2995a90a4ba8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA065398
Marketing category
ANDA
Marketing start
2019-09-17
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
61919-170-062023-01-30C16284748780-1f386c64a-3586-0266-e053-dadaa90a7c1aAZITHROMYCIN MONOHYDRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-170-06AZITHROMYCIN MONOHYDRATE6 in 1 BLISTER PACKTABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-170-06EA - Each61919-17004eddd3d-6a4a-4d8d-acb3-7deef34e614f12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-170AZITHROMYCIN MONOHYDRATE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190917_92c05d6e-133a-b404-e053-2995a90a4ba8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK92c05d6e-133a-b404-e053-2995a90a4ba81
308460azithromycin 250 MG Oral TabletPSN92c05d6e-133a-b404-e053-2995a90a4ba81
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN92c05d6e-133a-b404-e053-2995a90a4ba81
308460azithromycin 250 MG Oral TabletSCD92c05d6e-133a-b404-e053-2995a90a4ba81
749783azithromycin 250 MG Oral Tablet 6 Count PackSY92c05d6e-133a-b404-e053-2995a90a4ba81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-170-06619190170066 TABLET in 1 BLISTER PACK (61919-170-06) 6 tablet2019-09-170000-00-00NoNoCurrent