Azithromycin

Product NDC
0781-8089
11-digit product format
007818089
Labeler code
0781
Product ID
0781-8089_a43a036c-9af9-4429-b0c0-731001003fea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
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 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
A065211-001AZITHROMYCINAZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065211-001AB

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 UTC2026-02A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065211-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14cb3db0bc1861…

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 UTC2026-02A065211-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065211-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065211-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065211-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065211-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065211-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065211-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065211-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065211-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065211-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065211-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065211-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065211-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065211-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065211-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065211-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065211-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065211-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065211-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065211-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065211-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065211-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065211-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065211-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065211-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065211-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065211-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065211-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065211-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065211-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065211-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065211-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065211-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065211-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065211-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065211-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065211-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065211-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065211-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065211-001AB1cb3db0bc1861…

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 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
ec619299-e0ef-44dd-acdb-8c53bbfc5b8aAvailable 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
0781-8089-26Azithromycin6 in 1 CARTONTABLET, FILM COATED64
0781-8089-26Azithromycin1 in 1 DOSE PACKTABLET, FILM COATED14
0781-8089-31Azithromycin30 in 1 BOTTLETABLET, FILM COATED304
0781-8089-69Azithromycin5 in 1 CARTONTABLET, FILM COATED54
0781-8089-69Azithromycin10 in 1 BLISTER PACKTABLET, FILM COATED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8089-26EA - Each0781-808963485d32-04d8-458f-bf02-8daa83372ab212019-09-05
0781-8089-31EA - Each0781-8089b32b7635-7c54-4302-afc5-883a7b616d0212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8089AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]4Current NDC, Legacy NDC, 5 package rows20221202_ec619299-e0ef-44dd-acdb-8c53bbfc5b8a.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
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINSportpharm LLC60ec2020-148b-4a2a-96f2-dd09c590ecbb2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINAsclemed USA, Inc.22a4d2b3-daea-4d96-891f-4b98236294562024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINProficient Rx LP38942011-f86b-4e42-a4ca-05a70d9dd3d92024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2022-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065211
application number: ANDA065211
ndc (product): 0781-8089

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
308460azithromycin 250 MG Oral TabletPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
248656azithromycin 500 MG Oral TabletPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
308460azithromycin 250 MG Oral TabletSCDec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
248656azithromycin 500 MG Oral TabletSCDec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783azithromycin 250 MG Oral Tablet 6 Count PackSYec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749780azithromycin 500 MG Oral Tablet 3 Count PackSYec619299-e0ef-44dd-acdb-8c53bbfc5b8a4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK60ec2020-148b-4a2a-96f2-dd09c590ecbb3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK38942011-f86b-4e42-a4ca-05a70d9dd3d93
308460azithromycin 250 MG Oral TabletPSN60ec2020-148b-4a2a-96f2-dd09c590ecbb3
308460azithromycin 250 MG Oral TabletPSN38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN60ec2020-148b-4a2a-96f2-dd09c590ecbb3
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN38942011-f86b-4e42-a4ca-05a70d9dd3d93
308460azithromycin 250 MG Oral TabletSCD60ec2020-148b-4a2a-96f2-dd09c590ecbb3
308460azithromycin 250 MG Oral TabletSCD38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackSY38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackSY60ec2020-148b-4a2a-96f2-dd09c590ecbb3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK22a4d2b3-daea-4d96-891f-4b98236294562
308460azithromycin 250 MG Oral TabletPSN22a4d2b3-daea-4d96-891f-4b98236294562
308460azithromycin 250 MG Oral TabletPSNf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN22a4d2b3-daea-4d96-891f-4b98236294562
308460azithromycin 250 MG Oral TabletSCDf4c1e9ff-efd2-f3a5-e053-2995a90adda72
308460azithromycin 250 MG Oral TabletSCD22a4d2b3-daea-4d96-891f-4b98236294562
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf4c1e9ff-efd2-f3a5-e053-2995a90adda72
749783azithromycin 250 MG Oral Tablet 6 Count PackSY22a4d2b3-daea-4d96-891f-4b98236294562
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK661ff7a6-6394-493d-a307-a1f607e5d1171
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK661ff7a6-6394-493d-a307-a1f607e5d1171
308460azithromycin 250 MG Oral TabletPSN661ff7a6-6394-493d-a307-a1f607e5d1171
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG Oral TabletPSN661ff7a6-6394-493d-a307-a1f607e5d1171
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN661ff7a6-6394-493d-a307-a1f607e5d1171
308460azithromycin 250 MG Oral TabletSCD661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG Oral TabletSCD661ff7a6-6394-493d-a307-a1f607e5d1171
749783azithromycin 250 MG Oral Tablet 6 Count PackSY661ff7a6-6394-493d-a307-a1f607e5d1171
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY661ff7a6-6394-493d-a307-a1f607e5d1171
749780azithromycin 500 MG Oral Tablet 3 Count PackSY661ff7a6-6394-493d-a307-a1f607e5d1171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-8089-26007818089266 DOSE PACK in 1 CARTON (0781-8089-26) / 1 TABLET, FILM COATED in 1 DOSE PACK6 dose pack2019-02-140000-00-00NoNoCurrent
0781-8089-310078180893130 TABLET, FILM COATED in 1 BOTTLE (0781-8089-31) 2019-02-140000-00-00NoNoCurrent
0781-8089-69007818089695 BLISTER PACK in 1 CARTON (0781-8089-69) / 10 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2019-02-140000-00-00NoNoCurrent