FDA.reportPublic FDA data

Azithromycin

Product NDC
62332-252
11-digit product format
623320252
Labeler code
62332
Product ID
62332-252_a6585638-3730-443c-895f-b54980943d21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211792
Marketing category
ANDA
Marketing start
2020-01-29
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 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 DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656, 749780

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
62332-252-03Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED312
62332-252-03Azithromycin3 in 1 CARTONTABLET, FILM COATED312
62332-252-09Azithromycin3 in 1 CARTONTABLET, FILM COATED312
62332-252-09Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED312
62332-252-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-252AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 5 package rows20220301_45410338-6bff-476b-b8e1-6c6238205a99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN614cc2a4-3fc7-455d-9e8a-212c496f0fbf14
248656azithromycin 500 MG Oral TabletSCD614cc2a4-3fc7-455d-9e8a-212c496f0fbf14
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY614cc2a4-3fc7-455d-9e8a-212c496f0fbf14
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK45410338-6bff-476b-b8e1-6c6238205a9912
248656azithromycin 500 MG Oral TabletPSN45410338-6bff-476b-b8e1-6c6238205a9912
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN45410338-6bff-476b-b8e1-6c6238205a9912
248656azithromycin 500 MG Oral TabletSCD45410338-6bff-476b-b8e1-6c6238205a9912
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY45410338-6bff-476b-b8e1-6c6238205a9912
749780azithromycin 500 MG Oral Tablet 3 Count PackSY45410338-6bff-476b-b8e1-6c6238205a9912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-252-03623320252033 BLISTER PACK in 1 CARTON (62332-252-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-01-290000-00-00NoNoCurrent
62332-252-09623320252093 BLISTER PACK in 1 CARTON (62332-252-09) / 3 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-01-290000-00-00NoNoCurrent
62332-252-306233202523030 TABLET, FILM COATED in 1 BOTTLE (62332-252-30) 2020-01-290000-00-00NoNoCurrent