FDA.reportPublic FDA data

azithromycin

Product NDC
68180-862
11-digit product format
681800862
Labeler code
68180
Product ID
68180-862_94b31917-601f-41bc-a6c8-2873d5d719a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065399
Marketing category
ANDA
Marketing start
2015-08-18
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, 308460, 749780, 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
68180-862-06azithromycin30 in 1 CONTAINERTABLET, FILM COATED308
68180-862-11azithromycin1 in 1 CARTONTABLET, FILM COATED18
68180-862-11azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED38
68180-862-13azithromycin3 in 1 CARTONTABLET, FILM COATED38
68180-862-13azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-862AZITHROMYCIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20250410_01649d79-4677-4577-a3e4-e054f3f9fc3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK01649d79-4677-4577-a3e4-e054f3f9fc3b8
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK01649d79-4677-4577-a3e4-e054f3f9fc3b8
308460azithromycin 250 MG Oral TabletPSN01649d79-4677-4577-a3e4-e054f3f9fc3b8
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN01649d79-4677-4577-a3e4-e054f3f9fc3b8
248656azithromycin 500 MG Oral TabletPSN01649d79-4677-4577-a3e4-e054f3f9fc3b8
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN01649d79-4677-4577-a3e4-e054f3f9fc3b8
308460azithromycin 250 MG Oral TabletSCD01649d79-4677-4577-a3e4-e054f3f9fc3b8
248656azithromycin 500 MG Oral TabletSCD01649d79-4677-4577-a3e4-e054f3f9fc3b8
749783azithromycin 250 MG Oral Tablet 6 Count PackSY01649d79-4677-4577-a3e4-e054f3f9fc3b8
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY01649d79-4677-4577-a3e4-e054f3f9fc3b8
749780azithromycin 500 MG Oral Tablet 3 Count PackSY01649d79-4677-4577-a3e4-e054f3f9fc3b8
308460azithromycin 250 MG Oral TabletPSN814abe38-da4a-48af-bf4b-2ce04a5aabd15
248656azithromycin 500 MG Oral TabletPSN814abe38-da4a-48af-bf4b-2ce04a5aabd15
308460azithromycin 250 MG Oral TabletSCD814abe38-da4a-48af-bf4b-2ce04a5aabd15
248656azithromycin 500 MG Oral TabletSCD814abe38-da4a-48af-bf4b-2ce04a5aabd15
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY814abe38-da4a-48af-bf4b-2ce04a5aabd15
308460azithromycin 250 MG Oral TabletPSN6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG Oral TabletPSN6169e56c-10fb-448d-ab0f-14e54fcf28174
308460azithromycin 250 MG Oral TabletSCD6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG Oral TabletSCD6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY6169e56c-10fb-448d-ab0f-14e54fcf28174
248656azithromycin 500 MG Oral TabletPSNbf061799-cdef-40f8-b1ce-bc5eb609f8c33
248656azithromycin 500 MG Oral TabletSCDbf061799-cdef-40f8-b1ce-bc5eb609f8c33
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYbf061799-cdef-40f8-b1ce-bc5eb609f8c33
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK1cec44fa-9597-3e58-e063-6394a90ae3262
248656azithromycin 500 MG Oral TabletPSN1cec44fa-9597-3e58-e063-6394a90ae3262
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN1cec44fa-9597-3e58-e063-6394a90ae3262
248656azithromycin 500 MG Oral TabletSCD1cec44fa-9597-3e58-e063-6394a90ae3262
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY1cec44fa-9597-3e58-e063-6394a90ae3262
749780azithromycin 500 MG Oral Tablet 3 Count PackSY1cec44fa-9597-3e58-e063-6394a90ae3262
248656azithromycin 500 MG Oral TabletPSN26a53662-282d-b5da-e063-6394a90a6a4b1
248656azithromycin 500 MG Oral TabletSCD26a53662-282d-b5da-e063-6394a90a6a4b1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY26a53662-282d-b5da-e063-6394a90a6a4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-862-066818008620630 TABLET, FILM COATED in 1 CONTAINER (68180-862-06) 2022-11-170000-00-00NoNoCurrent
68180-862-11681800862111 BLISTER PACK in 1 CARTON (68180-862-11) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-11-170000-00-00NoNoCurrent
68180-862-13681800862133 BLISTER PACK in 1 CARTON (68180-862-13) > 3 TABLET in 1 BLISTER PACK3 blister pack2022-11-170000-00-00NoNoCurrent