AZITHROMYCIN MONOHYDRATE

Product NDC
61919-096
11-digit product format
619190096
Labeler code
61919
Product ID
61919-096_9c5970fb-9ba5-6e87-e053-2a95a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065399
Marketing category
ANDA
Marketing start
2017-03-08
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-096-032023-01-30C16284748780-1f386c649-f491-0266-e053-dadaa90a7c1aAZITHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-096-03AZITHROMYCIN MONOHYDRATE3 in 1 BLISTER PACKTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-096AZITHROMYCIN MONOHYDRATE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200128_4a3a000d-baee-74a3-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN4a3a000d-baee-74a3-e054-00144ff88e882
248656azithromycin 500 MG Oral TabletSCD4a3a000d-baee-74a3-e054-00144ff88e882
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY4a3a000d-baee-74a3-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-096-03619190096033 TABLET in 1 BLISTER PACK (61919-096-03) 3 tablet2017-03-080000-00-00NoNoCurrent