Azithromycin Dihydrate

Product NDC
50090-7298
11-digit product format
500907298
Labeler code
50090
Product ID
50090-7298_7c55988f-8092-42b4-b993-8ffb2fb0d85c
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
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7298-0Azithromycin Dihydrate5 in 1 BOTTLETABLET, FILM COATED51
50090-7298-1Azithromycin Dihydrate1 in 1 BOTTLETABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7298-0EA - Each50090-7298739fa48f-e388-42a2-93a5-115d216449ce12024-11-05
50090-7298-1EA - Each50090-729859925354-2a48-4fa0-ac9c-51b4c4a6816912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7298AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241016_fcf098d5-dfd5-4a0d-81f7-6afa1a203a27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNfcf098d5-dfd5-4a0d-81f7-6afa1a203a271
248656azithromycin 500 MG Oral TabletSCDfcf098d5-dfd5-4a0d-81f7-6afa1a203a271
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYfcf098d5-dfd5-4a0d-81f7-6afa1a203a271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7298-0500907298005 TABLET, FILM COATED in 1 BOTTLE (50090-7298-0) 2024-10-14NoNoCurrent
50090-7298-1500907298011 TABLET, FILM COATED in 1 BOTTLE (50090-7298-1) 2024-10-14NoNoCurrent