Application 065352

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATECAPSULE;ORALEQ 500MG BASENoNo

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
A065352-001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 500MG BASECAPSULE / ORALAB2007-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065352-001AB

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 UTC2026-02A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253f01610625f2…
2019-09-15 20:21 UTC2019-09A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25cb3db0bc1861…

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 UTC2026-02A065352-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065352-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065352-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065352-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065352-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065352-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065352-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065352-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065352-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065352-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065352-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065352-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065352-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065352-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065352-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065352-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065352-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065352-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065352-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065352-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065352-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065352-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065352-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065352-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065352-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065352-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065352-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065352-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065352-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065352-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065352-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065352-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065352-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065352-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065352-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065352-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065352-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065352-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065352-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065352-001AB1cb3db0bc1861…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefadroxilCEFADROXILRedpharm Drug4fb524c1-f985-2a8f-e063-6394a90aab7f2026-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILPreferred Pharmaceuticals Inc.41bc5f5a-5e1d-4cb6-a795-9f1756a8f0742026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILRedPharm Drug, Inc.97193a92-12ff-cfab-e053-2a95a90a9f142026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 67296-1727
CefadroxilCEFADROXILPD-Rx Pharmaceuticals, Inc.ab9cf28c-7c16-4bfa-879d-c360b4d1d5a62025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 43063-595
CEFADROXILCEFADROXILDIRECT RXa7e74b63-9d5c-7baa-e053-2a95a90a98b22025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 72189-103
CefadroxilCEFADROXILDirect_Rx02566385-46f3-255a-e063-6294a90a1d1c2024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.a218d8d3-af90-4599-e053-2995a90a0ede2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 68071-5234
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.8bdd68a4-4e2e-0170-e053-2a95a90adb782024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 68071-4938
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.7278a39f-9de1-c9e2-e053-2a91aa0aea342024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 68071-4515
CefadroxilCEFADROXILAdvanced Rx Pharmacy of Tennessee, LLC1a50b564-b00f-58e4-e063-6294a90af2c62024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.16f3dd01-650a-2426-e063-6394a90a1b4b2024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILBryant Ranch Prepack672519a7-11a1-4d8e-b2ca-dc9598c2f1792024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 63629-8253
CefadroxilCEFADROXILBryant Ranch Prepack9c3bed82-6df0-4643-944a-a826f7dc018f2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 63629-7988
CefadroxilCEFADROXILBryant Ranch Prepack8cdaac56-b84a-4b6b-b94d-cab15d5961c52024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 63629-7987
CefadroxilCEFADROXILA-S Medication Solutions41ab333a-fafb-4647-844e-f3b2a76723cb2024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 50090-6050
CefadroxilCEFADROXILAdvanced Rx Pharmacy of Tennessee, LLCec836a53-7ed1-79b9-e053-2a95a90a9c362024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 80425-0198
CefadroxilCEFADROXILRising Pharma Holdings, Inc.74c99fd8-16d1-4d2c-9158-42ff5eed2b7c2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 57237-096
CefadroxilCEFADROXILAurobindo Pharma Limited7bb90096-14d3-400e-94d3-048bff6b12922024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 65862-085
CefadroxilCEFADROXILNorthStar Rx LLC17123057-58c7-401a-b87d-8c4c0764bbf62024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
ndc (product): 16714-388

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-388CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-388CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-388CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-388CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
43063-595CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-595CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-595CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-595CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-595CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-595CefadroxilCefadroxilPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1915CefadroxilCefadroxilA-S Medication SolutionsANDACurrent
50090-6050CefadroxilCefadroxilA-S Medication SolutionsANDACurrent
57237-096CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-096CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-096CefadroxilCefadroxilRising Health, LLCANDACurrent
63629-7615CefadroxilCefadroxilBryant Ranch PrepackANDACurrent
63629-7615CefadroxilCefadroxilBryant Ranch PrepackANDACurrent
63629-7987CefadroxilCefadroxilBryant Ranch PrepackANDACurrent
63629-7988CefadroxilCefadroxilBryant Ranch PrepackANDACurrent
63629-8253CefadroxilCefadroxilBryant Ranch PrepackANDACurrent
65862-085CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-085CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-085CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
66267-768CefadroxilCefadroxilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-768CefadroxilCefadroxilNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1038CefadroxilCefadroxilRedPharm Drug, Inc.ANDACurrent
67296-1038CefadroxilCefadroxilRedPharm Drug, Inc.ANDACurrent
67296-1038CefadroxilCefadroxilRedPharm Drug, Inc.ANDACurrent
67296-1727CefadroxilCefadroxilRedPharm Drug, Inc.ANDACurrent
67296-1727CefadroxilCefadroxilRedPharm Drug, Inc.ANDACurrent
68071-2752CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3147CefadroxilCefadroxilNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4515CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4515CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4550CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4938CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4938CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5234CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5234CefadroxilCefadroxilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6416CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6416CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6416CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6416CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
68788-7484CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
68788-7484CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
68788-7484CefadroxilCefadroxilPreferred Pharmaceuticals Inc.ANDACurrent
70518-2271CefadroxilCefadroxilREMEDYREPACK INC.ANDACurrent
70518-2538CefadroxilCefadroxilREMEDYREPACK INC.ANDACurrent
70518-2538CefadroxilCefadroxilREMEDYREPACK INC.ANDACurrent
70518-2538CefadroxilCefadroxilREMEDYREPACK INC.ANDACurrent
70934-056CefadroxilCefadroxilDenton Pharma, Inc.ANDACurrent
70934-056CefadroxilCefadroxilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-056CefadroxilCefadroxilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-056CefadroxilCefadroxilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
72189-103CEFADROXILCEFADROXILDIRECT RXANDACurrent
72189-103CEFADROXILCEFADROXILDIRECT RXANDACurrent
80425-0198CefadroxilCefadroxilAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent