FDA.reportPublic FDA data

Azithromycin

Product NDC
42291-083
11-digit product format
422910083
Labeler code
42291
Product ID
42291-083_4d3a5007-c37f-70b6-e063-6394a90acf0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA210001
Marketing category
ANDA
Marketing start
2022-04-11
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656, 308460

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
42291-083-03Azithromycin3 in 1 BOTTLETABLET, FILM COATED34
42291-083-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-083-03EA - Each42291-08329533a7e-c038-4f9c-bb39-313a10c270c512022-05-04
42291-083-30EA - Each42291-08394b2160e-2083-4201-b8c9-62be4fd7a59912022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-083AZITHROMYCIN TABLET, FILM COATED [AVKARE]2Current NDC, Legacy NDC, 2 package rows20240110_dc633b7d-5154-7e43-e053-2a95a90ad2a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG Oral TabletPSNdc633b7d-5154-7e43-e053-2a95a90ad2a64
308460azithromycin 250 MG Oral TabletSCDdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG Oral TabletSCDdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYdc633b7d-5154-7e43-e053-2a95a90ad2a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-083-03422910083033 TABLET, FILM COATED in 1 BOTTLE (42291-083-03) 2022-04-110000-00-00NoNoCurrent
42291-083-304229100833030 TABLET, FILM COATED in 1 BOTTLE (42291-083-30) 2022-04-110000-00-00NoNoCurrent