FDA.reportPublic FDA data

azithromycin

Product NDC
68180-861
11-digit product format
681800861
Labeler code
68180
Product ID
68180-861_94b31917-601f-41bc-a6c8-2873d5d719a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065398
Marketing category
ANDA
Marketing start
2022-11-17
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
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
68180-861-06azithromycin30 in 1 CONTAINERTABLET, FILM COATED308
68180-861-11azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED68
68180-861-13azithromycin3 in 1 CARTONTABLET, FILM COATED38
68180-861-13azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-861-06EA - Each68180-86127d7661a-9fd1-409e-9679-2718324394ce12023-02-06
68180-861-11EA - Each68180-861c625b36a-acbe-47b1-9e2f-eb2b4365a63612023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-861AZITHROMYCIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 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
308460azithromycin 250 MG Oral TabletPSNda399401-1ee6-422a-be46-0bba6b264b2f3
308460azithromycin 250 MG Oral TabletSCDda399401-1ee6-422a-be46-0bba6b264b2f3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK25bc2e78-9d0d-41c6-a55e-a267d44579671
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK20ae108a-00c5-a984-e063-6394a90aaaae1
308460azithromycin 250 MG Oral TabletPSN510024c9-6658-e08f-e063-6294a90a07931
308460azithromycin 250 MG Oral TabletPSN25bc2e78-9d0d-41c6-a55e-a267d44579671
308460azithromycin 250 MG Oral TabletPSN20ae108a-00c5-a984-e063-6394a90aaaae1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN25bc2e78-9d0d-41c6-a55e-a267d44579671
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN20ae108a-00c5-a984-e063-6394a90aaaae1
308460azithromycin 250 MG Oral TabletSCD510024c9-6658-e08f-e063-6294a90a07931
308460azithromycin 250 MG Oral TabletSCD25bc2e78-9d0d-41c6-a55e-a267d44579671
308460azithromycin 250 MG Oral TabletSCD20ae108a-00c5-a984-e063-6394a90aaaae1
749783azithromycin 250 MG Oral Tablet 6 Count PackSY25bc2e78-9d0d-41c6-a55e-a267d44579671
749783azithromycin 250 MG Oral Tablet 6 Count PackSY20ae108a-00c5-a984-e063-6394a90aaaae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-861-066818008610630 TABLET, FILM COATED in 1 CONTAINER (68180-861-06) 2022-11-170000-00-00NoNoCurrent
68180-861-11681800861116 TABLET, FILM COATED in 1 BLISTER PACK (68180-861-11) 2022-11-170000-00-00NoNoCurrent
68180-861-13681800861133 BLISTER PACK in 1 CARTON (68180-861-13) > 6 TABLET in 1 BLISTER PACK3 blister pack2022-11-170000-00-00NoNoCurrent