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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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