FDA.reportPublic FDA data

Azithromycin

Product NDC
68788-8124
11-digit product format
687888124
Labeler code
68788
Product ID
68788-8124_661ff7a6-6394-493d-a307-a1f607e5d117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065211
Marketing category
ANDA
Marketing start
2022-01-10
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-8124-62024-01-30C16284748780-11030e365-2a4c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8124-6Azithromycin1 in 1 DOSE PACKTABLET, FILM COATED11
68788-8124-6Azithromycin6 in 1 CARTONTABLET, FILM COATED61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8124-6EA - Each68788-8124d0ee5bfc-10d1-4a51-8abc-1cbe13c3dd8212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8124AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20220111_661ff7a6-6394-493d-a307-a1f607e5d117.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK661ff7a6-6394-493d-a307-a1f607e5d1171
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK661ff7a6-6394-493d-a307-a1f607e5d1171
308460azithromycin 250 MG Oral TabletPSN661ff7a6-6394-493d-a307-a1f607e5d1171
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG Oral TabletPSN661ff7a6-6394-493d-a307-a1f607e5d1171
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN661ff7a6-6394-493d-a307-a1f607e5d1171
308460azithromycin 250 MG Oral TabletSCD661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG Oral TabletSCD661ff7a6-6394-493d-a307-a1f607e5d1171
749783azithromycin 250 MG Oral Tablet 6 Count PackSY661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY661ff7a6-6394-493d-a307-a1f607e5d1171
749780azithromycin 500 MG Oral Tablet 3 Count PackSY661ff7a6-6394-493d-a307-a1f607e5d1171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8124-6687888124066 DOSE PACK in 1 CARTON (68788-8124-6) > 1 TABLET, FILM COATED in 1 DOSE PACK6 dose pack2022-01-100000-00-00NoNoCurrent