Azithromycin Dihydrate

Product NDC
45865-641
11-digit product format
458650641
Labeler code
45865
Product ID
45865-641_7205c0e2-d7a7-3451-e053-2a95a90a69b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA065507
Marketing category
ANDA
Marketing start
2011-07-18
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-641-06Azithromycin Dihydrate6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-641AZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20180728_7205c0e2-d7a6-3451-e053-2a95a90a69b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK7205c0e2-d7a6-3451-e053-2a95a90a69b01
308460azithromycin 250 MG Oral TabletPSN7205c0e2-d7a6-3451-e053-2a95a90a69b01
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN7205c0e2-d7a6-3451-e053-2a95a90a69b01
308460azithromycin 250 MG Oral TabletSCD7205c0e2-d7a6-3451-e053-2a95a90a69b01
749783azithromycin 250 MG Oral Tablet 6 Count PackSY7205c0e2-d7a6-3451-e053-2a95a90a69b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-641-06458650641066 in 1 BOTTLEHistorical