FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
50268-074
11-digit product format
502680074
Labeler code
50268
Product ID
50268-074_47e22fe1-c6d6-576b-e063-6394a90a98e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA208250
Marketing category
ANDA
Marketing start
2020-12-11
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
Rxcui248656, 308460

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
50268-074-11Azithromycin Dihydrate1 in 1 BLISTER PACKTABLET, FILM COATED18
50268-074-13Azithromycin Dihydrate30 in 1 BOXTABLET, FILM COATED308
50268-074-15Azithromycin Dihydrate50 in 1 BOXTABLET, FILM COATED508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-074-11EA - Each50268-0748ff51402-fbd7-419f-9219-003c4cf7a07c12021-02-05
50268-074-13EA - Each50268-0741152e6eb-f21e-4232-b569-addd391b844012021-02-05
50268-074-15EA - Each50268-07449056dfe-db48-4f95-82a9-92bc00a0ffb112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-074AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [AVPAK]7Current NDC, Legacy NDC, 3 package rows20240921_b635019e-7fd4-7f9e-e053-2a95a90a388c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletPSNb635019e-7fd4-7f9e-e053-2a95a90a388c8
308460azithromycin 250 MG Oral TabletSCDb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletSCDb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb635019e-7fd4-7f9e-e053-2a95a90a388c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-074-11502680074111 in 1 BLISTER PACKHistorical
50268-074-135026800741330 BLISTER PACK in 1 BOX (50268-074-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-074-11) 30 blister pack2020-12-110000-00-00NoNoCurrent
50268-074-155026800741550 BLISTER PACK in 1 BOX (50268-074-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-074-11) 50 blister pack2021-08-260000-00-00NoNoCurrent