Azithromycin Dihydrate

Product NDC
50090-4528
11-digit product format
500904528
Labeler code
50090
Product ID
50090-4528_de1a2f78-27f4-4b3c-b540-3fc9be8196c2
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
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4528-0Azithromycin Dihydrate5 in 1 BOTTLETABLET, FILM COATED56
50090-4528-1Azithromycin Dihydrate1 in 1 BOTTLETABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4528-0EA - Each50090-452810431f5c-9a74-4477-bc03-b00df8b929ac12022-07-06
50090-4528-1EA - Each50090-4528af52bb2c-f739-4f99-9b64-65dec3ce8e6d12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4528AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20211029_0494df57-f514-4274-8e38-dd79023fedb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN0494df57-f514-4274-8e38-dd79023fedb06
248656azithromycin 500 MG Oral TabletSCD0494df57-f514-4274-8e38-dd79023fedb06
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY0494df57-f514-4274-8e38-dd79023fedb06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4528-0500904528005 TABLET, FILM COATED in 1 BOTTLE (50090-4528-0) 2019-09-170000-00-00NoNoCurrent
50090-4528-1500904528011 TABLET, FILM COATED in 1 BOTTLE (50090-4528-1) 2019-09-170000-00-00NoNoCurrent