FDA.reportPublic FDA data

Azithromycin

Product NDC
62332-251
11-digit product format
623320251
Labeler code
62332
Product ID
62332-251_ec17228a-6191-4f77-8ae2-00da7c85fca3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211791
Marketing category
ANDA
Marketing start
2020-01-29
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-251-06Azithromycin18 in 1 CARTONTABLET, FILM COATED1813
62332-251-06Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED613
62332-251-18Azithromycin18 in 1 CARTONTABLET, FILM COATED1813
62332-251-18Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED613
62332-251-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED3013
62332-251-71Azithromycin500 in 1 BOTTLETABLET, FILM COATED50013
62332-251-91Azithromycin1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-251-06EA - Each62332-251bd3bc526-db06-4025-9a49-83ed324453f312022-02-07
62332-251-30EA - Each62332-25124124145-c70e-4e42-9edc-ed4d6a0440c312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-251AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 7 package rows20240224_4314da8a-40e5-4aba-a32b-57b4166ade30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4314da8a-40e5-4aba-a32b-57b4166ade3013
308460azithromycin 250 MG Oral TabletPSN4314da8a-40e5-4aba-a32b-57b4166ade3013
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4314da8a-40e5-4aba-a32b-57b4166ade3013
308460azithromycin 250 MG Oral TabletSCD4314da8a-40e5-4aba-a32b-57b4166ade3013
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4314da8a-40e5-4aba-a32b-57b4166ade3013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-251-066233202510618 BLISTER PACK in 1 CARTON (62332-251-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK18 blister pack2020-01-290000-00-00NoNoCurrent
62332-251-186233202511818 BLISTER PACK in 1 CARTON (62332-251-18) / 6 TABLET, FILM COATED in 1 BLISTER PACK18 blister pack2020-01-290000-00-00NoNoCurrent
62332-251-306233202513030 TABLET, FILM COATED in 1 BOTTLE (62332-251-30) 2020-01-290000-00-00NoNoCurrent
62332-251-7162332025171500 TABLET, FILM COATED in 1 BOTTLE (62332-251-71) 2024-01-26NoNoCurrent
62332-251-91623320251911000 TABLET, FILM COATED in 1 BOTTLE (62332-251-91) 2024-01-26NoNoCurrent