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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065398-001AZITHROMYCINAZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A065398-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065398-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2015-05-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065398-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065398-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065398-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065398-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065398-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065398-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065398-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065398-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065398-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065398-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065398-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065398-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065398-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065398-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065398-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065398-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065398-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065398-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065398-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065398-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065398-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065398-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065398-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065398-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065398-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065398-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065398-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065398-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065398-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065398-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065398-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065398-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065398-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065398-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065398-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065398-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065398-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065398-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065398-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065398-001AB1e64feba35796…

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

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
azithromycinAZITHROMYCINCoupler LLC510024c9-6658-e08f-e063-6294a90a07932026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
azithromycinAZITHROMYCINCardinal Health 107, LLCea128124-8712-4998-be46-47d43ef127d42026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
ndc (product): 68180-861
azithromycinAZITHROMYCINREMEDYREPACK INC.da399401-1ee6-422a-be46-0bba6b264b2f2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
AzithromycinAZITHROMYCINAmerican Health Packaging6169e56c-10fb-448d-ab0f-14e54fcf28172025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
azithromycinAZITHROMYCINProficient Rx LP25bc2e78-9d0d-41c6-a55e-a267d44579672025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC20ae108a-00c5-a984-e063-6394a90aaaae2024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065398
application number: ANDA065398

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