FDA.reportPublic FDA data

Azithromycin

Product NDC
42291-082
11-digit product format
422910082
Labeler code
42291
Product ID
42291-082_4d3a5007-c37f-70b6-e063-6394a90acf0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA210000
Marketing category
ANDA
Marketing start
2022-04-11
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

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
42291-082-06Azithromycin6 in 1 BOTTLETABLET, FILM COATED64
42291-082-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-082-06EA - Each42291-082e00bd76b-6d18-4dc6-9472-b8cf7f01285712022-05-04
42291-082-30EA - Each42291-0823e6383f2-cc75-4f04-8e44-f08b6531eba612022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-082AZITHROMYCIN 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
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKb77b347d-d357-4bdf-b985-49d9a1dd634c1
308460azithromycin 250 MG Oral TabletPSNb77b347d-d357-4bdf-b985-49d9a1dd634c1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNb77b347d-d357-4bdf-b985-49d9a1dd634c1
308460azithromycin 250 MG Oral TabletSCDb77b347d-d357-4bdf-b985-49d9a1dd634c1
749783azithromycin 250 MG Oral Tablet 6 Count PackSYb77b347d-d357-4bdf-b985-49d9a1dd634c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-082-06422910082066 TABLET, FILM COATED in 1 BOTTLE (42291-082-06) 2022-04-110000-00-00NoNoCurrent
42291-082-304229100823030 TABLET, FILM COATED in 1 BOTTLE (42291-082-30) 2022-04-110000-00-00NoNoCurrent