FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
68788-8773
11-digit product format
687888773
Labeler code
68788
Product ID
68788-8773_5d400ebb-9edc-4753-9764-8d3aa9aeba41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2024-11-20
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8773-3Azithromycin Dihydrate3 in 1 BOTTLETABLET, FILM COATED32
68788-8773-4Azithromycin Dihydrate4 in 1 BOTTLETABLET, FILM COATED42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8773-3EA - Each68788-8773e65c07fc-887e-4dce-8713-b161a0bafc2a12025-02-10
68788-8773-4EA - Each68788-8773bf405d6e-acce-4315-bc19-db6d6defeec412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8773AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241122_3b90572c-cc24-49f0-baaf-09022a2f9a00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN3b90572c-cc24-49f0-baaf-09022a2f9a002
248656azithromycin 500 MG Oral TabletSCD3b90572c-cc24-49f0-baaf-09022a2f9a002
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY3b90572c-cc24-49f0-baaf-09022a2f9a002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8773-3687888773033 TABLET, FILM COATED in 1 BOTTLE (68788-8773-3) 2024-11-20NoNoHistorical
68788-8773-4687888773044 TABLET, FILM COATED in 1 BOTTLE (68788-8773-4) 2024-11-20NoNoHistorical