FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
62332-253
11-digit product format
623320253
Labeler code
62332
Product ID
62332-253_c043ed24-ba88-4465-a0bd-da8531778957
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-253-10AZITHROMYCIN10 in 1 BLISTER PACKTABLET, FILM COATED109
62332-253-10AZITHROMYCIN100 in 1 CARTONTABLET, FILM COATED1009
62332-253-30AZITHROMYCIN30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-253-30EA - Each62332-2538ef9fd04-3e69-45de-ac9c-f222c671d0b612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-253AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20211225_90e65b83-32d6-40bc-be5d-19fbec051bdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204844azithromycin 600 MG Oral TabletPSN90e65b83-32d6-40bc-be5d-19fbec051bdf9
204844azithromycin 600 MG Oral TabletSCD90e65b83-32d6-40bc-be5d-19fbec051bdf9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-253-1062332025310100 BLISTER PACK in 1 CARTON (62332-253-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2020-01-280000-00-00NoNoCurrent
62332-253-306233202533030 TABLET, FILM COATED in 1 BOTTLE (62332-253-30) 2020-01-280000-00-00NoNoCurrent