FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
85766-042
11-digit product format
857660042
Labeler code
85766
Product ID
85766-042_4a2bff9c-8890-4ac6-e063-6294a90ad59f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA208249
Marketing category
ANDA
Marketing start
2024-02-15
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, 749780

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
85766-042-03Azithromycin Dihydrate3 in 1 BLISTER PACKTABLET, FILM COATED32
85766-042-03Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED12
85766-042-09Azithromycin Dihydrate3 in 1 BOXTABLET, FILM COATED32
85766-042-09Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG Oral TabletPSN11446677-a3dc-40cb-897d-7a9851b8c89c2
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG Oral TabletSCD11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY11446677-a3dc-40cb-897d-7a9851b8c89c2
749780azithromycin 500 MG Oral Tablet 3 Count PackSY11446677-a3dc-40cb-897d-7a9851b8c89c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-042-03857660042031 BLISTER PACK in 1 CARTON (85766-042-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-08-07NoNoHistorical
85766-042-09857660042093 CARTON in 1 BOX (85766-042-09) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK3 carton2024-02-15NoNoHistorical