FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
50090-4700
11-digit product format
500904700
Labeler code
50090
Product ID
50090-4700_fd1fcc97-fc81-4396-a789-b92409cbf4a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208249
Marketing category
ANDA
Marketing start
2019-07-01
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4700-02023-02-07C16284748780-1f386c649-e405-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-4700-02023-01-30C16284748780-1f386c649-e405-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4700-0Azithromycin Dihydrate3 in 1 BOXTABLET, FILM COATED35
50090-4700-0Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4700-0EA - Each50090-4700db5b0685-88fd-4d73-bfbe-e6539610c36e12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4700AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230208_0f36ba37-a742-41c1-ad2d-b890a1d49c55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG Oral TabletPSN0f36ba37-a742-41c1-ad2d-b890a1d49c555
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG Oral TabletSCD0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY0f36ba37-a742-41c1-ad2d-b890a1d49c555
749780azithromycin 500 MG Oral Tablet 3 Count PackSY0f36ba37-a742-41c1-ad2d-b890a1d49c555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4700-0500904700003 CARTON in 1 BOX (50090-4700-0) / 1 TABLET, FILM COATED in 1 CARTON3 carton2019-11-080000-00-00NoNoCurrent