AZITHROMYCIN

Product NDC
72189-093
11-digit product format
721890093
Labeler code
72189
Product ID
72189-093_4d3a98e6-31e9-c271-e063-6394a90aa19e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA210000
Marketing category
ANDA
Marketing start
2020-05-15
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656, 308460, 749780, 749783

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
72189-093-06AZITHROMYCIN6 in 1 BLISTER PACKTABLET, FILM COATED67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-093-06EA - Each72189-093cf2d66c0-4038-43ac-9dc1-12716d01c27d12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-093AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [DIRECT RX]6Current NDC, Legacy NDC, 1 package rows20241116_a5b4092d-ab72-f5d1-e053-2995a90ac582.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-093-06721890093066 TABLET, FILM COATED in 1 BLISTER PACK (72189-093-06) 2020-05-150000-00-00NoNoCurrent