FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
68788-8800
11-digit product format
687888800
Labeler code
68788
Product ID
68788-8800_743a81de-0dea-4b20-b00c-76b89ec62797
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2025-01-01
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460, 749783

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
68788-8800-6Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED12
68788-8800-6Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8800-6EA - Each68788-8800eca58684-00f9-4efc-842a-6cc130e3f33812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8800AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250101_b3c84aea-7ba7-4aae-999c-db740a9e53df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKb3c84aea-7ba7-4aae-999c-db740a9e53df2
308460azithromycin 250 MG Oral TabletPSNb3c84aea-7ba7-4aae-999c-db740a9e53df2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNb3c84aea-7ba7-4aae-999c-db740a9e53df2
308460azithromycin 250 MG Oral TabletSCDb3c84aea-7ba7-4aae-999c-db740a9e53df2
749783azithromycin 250 MG Oral Tablet 6 Count PackSYb3c84aea-7ba7-4aae-999c-db740a9e53df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8800-6687888800061 BLISTER PACK in 1 CARTON (68788-8800-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-01-01NoNoCurrent