FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
46708-253
11-digit product format
467080253
Labeler code
46708
Product ID
46708-253_6a2f7a6c-a45d-448d-8f56-5bd7a5309a2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211793
Marketing category
ANDA
Marketing start
2020-01-28
Substance
AZITHROMYCIN DIHYDRATE
Active strength
600 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AZITHROMYCIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui204844

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
46708-253-102023-02-01C16284748780-1f386c64a-20e6-0266-e053-dadaa90a7c1aThese 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
46708-253-302023-02-01C16284748780-1f386c64a-20e6-0266-e053-dadaa90a7c1aThese 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
46708-253-10AZITHROMYCIN100 in 1 CARTONTABLET, FILM COATED1002
46708-253-10AZITHROMYCIN10 in 1 BLISTER PACKTABLET, FILM COATED102
46708-253-30AZITHROMYCIN30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-253AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 3 package rows20230202_5dca5a11-3c02-4a51-a35d-f91f37b8e00c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204844azithromycin 600 MG Oral TabletPSN5dca5a11-3c02-4a51-a35d-f91f37b8e00c2
204844azithromycin 600 MG Oral TabletSCD5dca5a11-3c02-4a51-a35d-f91f37b8e00c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-253-1046708025310100 BLISTER PACK in 1 CARTON (46708-253-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2020-01-280000-00-00NoNoCurrent
46708-253-304670802533030 TABLET, FILM COATED in 1 BOTTLE (46708-253-30) 2020-01-280000-00-00NoNoCurrent