FDA.reportPublic FDA data

Azithromycin

Product NDC
63629-8251
11-digit product format
636298251
Labeler code
63629
Product ID
63629-8251_cccc52bf-178d-42ba-9731-76dd4681f19b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
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

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
63629-8251-12024-09-10C16284748780-11030e365-5aee-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
63629-8251-22024-09-10C16284748780-11030e365-5aee-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
63629-8251-12024-01-30C16284748780-11030e365-5aee-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
63629-8251-22024-01-30C16284748780-11030e365-5aee-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
63629-8251-1Azithromycin30 in 1 BOTTLETABLET, FILM COATED306
63629-8251-2Azithromycin5 in 1 BOTTLETABLET, FILM COATED56
63629-8251-3Azithromycin2 in 1 BOTTLETABLET, FILM COATED26
63629-8251-4Azithromycin6 in 1 BOTTLETABLET, FILM COATED66
63629-8251-5Azithromycin4 in 1 BOTTLETABLET, FILM COATED46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8251AZITHROMYCIN TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20250326_a81212ef-76b6-4bd7-8706-3d2b05ee34f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNa81212ef-76b6-4bd7-8706-3d2b05ee34f96
248656azithromycin 500 MG Oral TabletSCDa81212ef-76b6-4bd7-8706-3d2b05ee34f96
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa81212ef-76b6-4bd7-8706-3d2b05ee34f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8251-16362982510130 TABLET, FILM COATED in 1 BOTTLE (63629-8251-1) 2019-12-180000-00-00NoNoCurrent
63629-8251-2636298251025 TABLET, FILM COATED in 1 BOTTLE (63629-8251-2) 2019-11-050000-00-00NoNoCurrent
63629-8251-3636298251032 TABLET, FILM COATED in 1 BOTTLE (63629-8251-3) 2019-11-05NoNoCurrent
63629-8251-4636298251046 TABLET, FILM COATED in 1 BOTTLE (63629-8251-4) 2019-11-05NoNoCurrent
63629-8251-5636298251054 TABLET, FILM COATED in 1 BOTTLE (63629-8251-5) 2019-11-05NoNoCurrent