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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065399-001AZITHROMYCINAZITHROMYCINEQ 500MG 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
A065399-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065399-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2015-05-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065399-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065399-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065399-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065399-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065399-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065399-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065399-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065399-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065399-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065399-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065399-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065399-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065399-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065399-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065399-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065399-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065399-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065399-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065399-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065399-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065399-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065399-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065399-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065399-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065399-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065399-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065399-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065399-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065399-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065399-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065399-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065399-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065399-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065399-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065399-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065399-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065399-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065399-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065399-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065399-001AB1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5FD1131I7SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248656Internal RxNorm lookup
308460Internal RxNorm lookup
749780Internal RxNorm lookup
749783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
01649d79-4677-4577-a3e4-e054f3f9fc3bAvailable on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-862-06EA - Each68180-862aba44aab-ca3e-4b7e-8f9e-11ea456a193012023-02-06
68180-862-11EA - Each68180-862ff4a4ebc-f851-4256-8a22-ea2dbce4623512023-02-06

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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
ndc (product): 68180-862
azithromycinAZITHROMYCINREMEDYREPACK INC.bf061799-cdef-40f8-b1ce-bc5eb609f8c32025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
AzithromycinAZITHROMYCINAmerican Health Packaging6169e56c-10fb-448d-ab0f-14e54fcf28172025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC1cec44fa-9597-3e58-e063-6394a90ae3262024-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065399
application number: ANDA065399

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