Azithromycin Dihydrate

Product NDC
50090-7506
11-digit product format
500907506
Labeler code
50090
Product ID
50090-7506_37b443e6-54a1-4c09-b097-2ea9cc785d49
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
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

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
50090-7506-0Azithromycin Dihydrate3 in 1 BOXTABLET, FILM COATED34
50090-7506-0Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7506-0EA - Each50090-7506d3d7ca59-4121-4861-9e2a-0f6aad85469b12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7506AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20250226_de5b0c2b-9a7d-46e9-8169-4100442efa9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNde5b0c2b-9a7d-46e9-8169-4100442efa9b4
248656azithromycin 500 MG Oral TabletSCDde5b0c2b-9a7d-46e9-8169-4100442efa9b4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYde5b0c2b-9a7d-46e9-8169-4100442efa9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7506-0500907506003 CARTON in 1 BOX (50090-7506-0) / 1 TABLET, FILM COATED in 1 CARTON3 carton2025-02-17NoNoHistorical