AZITHROMYCIN

Product NDC
61919-382
11-digit product format
619190382
Labeler code
61919
Product ID
61919-382_47d2d292-7798-4416-834e-4c35983ace85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065246
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-382-302020-01-31C16284748780-19d75b9d0-a6b4-f424-e053-dadaa90a57ceAZITHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-382-30AZITHROMYCIN30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-382AZITHROMYCIN POWDER, FOR SUSPENSION [DIRECT RX]3Legacy NDC, 1 package rows20150807_5c756d25-d561-4cd2-9da3-89aacc72a154.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN5c756d25-d561-4cd2-9da3-89aacc72a1543
141963azithromycin 40 MG/ML Oral SuspensionSCD5c756d25-d561-4cd2-9da3-89aacc72a1543
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY5c756d25-d561-4cd2-9da3-89aacc72a1543
141963azithromycin 200 MG per 5 ML Oral SuspensionSY5c756d25-d561-4cd2-9da3-89aacc72a1543
141963azithromycin 600 MG per 15 ML Oral SuspensionSY5c756d25-d561-4cd2-9da3-89aacc72a1543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61919-382-306191903823030 mL in 1 BOTTLE30 mlHistorical