FDA.reportPublic FDA data

AZITHROMYCIN DIHYDRATE

Product NDC
72189-090
11-digit product format
721890090
Labeler code
72189
Product ID
72189-090_4d3a97f3-7ddd-c49d-e063-6394a90a84ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN DIHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208249
Marketing category
ANDA
Marketing start
2020-05-22
Marketing end
2026-10-31
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AZITHROMYCIN DIHYDRATE

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
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
72189-090-02AZITHROMYCIN DIHYDRATE2 in 1 BOXTABLET, FILM COATED24
72189-090-03AZITHROMYCIN DIHYDRATE3 in 1 BOXTABLET, FILM COATED34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-090-02EA - Each72189-0908c127d17-f5a0-45a7-b56f-8b717c6a155d12022-12-07
72189-090-03EA - Each72189-0908a0538ab-0c45-48a8-b03e-ca1b55e3a7a512020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-090AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [DIRECT RX]3Current NDC, Legacy NDC, 2 package rows20250119_a6426d5f-5518-3c69-e053-2995a90af50f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa6426d5f-5518-3c69-e053-2995a90af50f4
248656azithromycin 500 MG Oral TabletPSNa6426d5f-5518-3c69-e053-2995a90af50f4
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa6426d5f-5518-3c69-e053-2995a90af50f4
248656azithromycin 500 MG Oral TabletSCDa6426d5f-5518-3c69-e053-2995a90af50f4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa6426d5f-5518-3c69-e053-2995a90af50f4
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa6426d5f-5518-3c69-e053-2995a90af50f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-090-02721890090022 TABLET, FILM COATED in 1 BOX (72189-090-02) 2020-05-222026-10-31NoNoCurrent
72189-090-03721890090033 TABLET, FILM COATED in 1 BOX (72189-090-03) 2020-05-222026-10-31NoNoCurrent