Application 065489

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARITHROMYCINCLARITHROMYCINTABLET;ORAL250MGNoYes
002CLARITHROMYCINCLARITHROMYCINTABLET;ORAL500MGNoYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065489-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25
A065489-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065489-001AB
A065489-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065489-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065489-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065489-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065489-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065489-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065489-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065489-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065489-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065489-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065489-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065489-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065489-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065489-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065489-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065489-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065489-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065489-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065489-002AB1782e0a99824c…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINSportpharm LLCd836ae7e-fdbf-4dcb-a90d-ede1dcbc3e672026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINREMEDYREPACK INC.9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c62026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 70518-0204
ClarithromycinCLARITHROMYCINProficient Rx LP88c7ded8-333c-408d-b693-a72881710f592026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINPreferred Pharmaceuticals Inc.81c0c69e-b1ae-42f3-9e85-09b8daa75d8d2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINMajor Pharmaceuticalsd0a66646-6774-4fc6-9b26-a98c3a5df2742026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 0904-6872
ClarithromycinCLARITHROMYCINAmerican Health Packagingfa69ea92-0b41-43fb-918f-ed80e0dedf042026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINAvPAK1920f943-bbf1-cfd9-7475-96a35680a9e02026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 50268-178
ndc (product): 50268-179
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLC471f638a-9dd1-09d3-e063-6294a90a2d4f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINDirect_Rx3ba1da51-ba5b-323f-e063-6294a90a03332025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.ba216276-b0bd-420a-9e0d-090bdfcc24602025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 43063-823
ClarithromycinCLARITHROMYCINA-S Medication Solutions25debd85-0840-4f8d-9898-027772061dd22025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 50090-1830
ClarithromycinCLARITHROMYCINNuCare Pharmaceuticals,Inc.9143b79c-4c79-43ac-e053-2995a90ad7082025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 68071-5045
ClarithromycinCLARITHROMYCINBryant Ranch Prepack0c7d8391-50ef-4827-abe6-e0fc0c2f16362024-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 71335-0017
ClarithromycinCLARITHROMYCINRising Pharma Holdings, Inc.0c4db97f-f4c9-4cac-9f12-9db1d967ebeb2024-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 57237-044
ndc (product): 57237-045
ClarithromycinCLARITHROMYCINAurobindo Pharma Limited9aaffb41-408c-4372-8fd5-1d649450c0e92023-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 65862-226
ndc (product): 65862-225
ClarithromycinCLARITHROMYCINA-S Medication Solutions1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea232023-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINProficient Rx LPb1bdf526-4f16-4130-b614-4cb678f060d72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ndc (product): 63187-625

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6872ClarithromycinClarithromycinMajor PharmaceuticalsANDACurrent
0904-6872ClarithromycinClarithromycinMajor PharmaceuticalsANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, InANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-823ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1830ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-1830ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-1830ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50268-178ClarithromycinClarithromycinAvPAKANDACurrent
50268-178ClarithromycinClarithromycinAvPAKANDACurrent
50268-178ClarithromycinClarithromycinAvPAKANDACurrent
50268-179ClarithromycinClarithromycinAvPAKANDACurrent
50268-179ClarithromycinClarithromycinAvPAKANDACurrent
50268-179ClarithromycinClarithromycinAvPAKANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-044ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
57237-045ClarithromycinClarithromycinRising Health, LLCANDACurrent
63187-625ClarithromycinClarithromycinProficient Rx LPANDACurrent
63187-625ClarithromycinClarithromycinProficient Rx LPANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-225ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
65862-226ClarithromycinClarithromycinAurobindo Pharma LimitedANDACurrent
67296-1632ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
67296-1632ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
68071-1899ClarithromycinClarithromycinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5045ClarithromycinClarithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6936ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6936ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0204ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
70518-0204ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0017ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent