Azithromycin Dihydrate

Product NDC
68071-2878
11-digit product format
680712878
Labeler code
68071
Product ID
68071-2878_edb07094-9950-c7cf-e053-2a95a90ab494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2019-07-01
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2878-6Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED11
68071-2878-6Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2878AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20221118_edb07524-489a-788e-e053-2a95a90a0eea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKedb07524-489a-788e-e053-2a95a90a0eea1
308460azithromycin 250 MG Oral TabletPSNedb07524-489a-788e-e053-2a95a90a0eea1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNedb07524-489a-788e-e053-2a95a90a0eea1
308460azithromycin 250 MG Oral TabletSCDedb07524-489a-788e-e053-2a95a90a0eea1
749783azithromycin 250 MG Oral Tablet 6 Count PackSYedb07524-489a-788e-e053-2a95a90a0eea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2878-6680712878061 BLISTER PACK in 1 CARTON (68071-2878-6) > 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-11-170000-00-00NoNoCurrent