Application 065135

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 250MG BASENoNo
002CEFUROXIME AXETILCEFUROXIME AXETILTABLET;ORALEQ 500MG BASENoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065135-001CEFUROXIME AXETILCEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25
A065135-002CEFUROXIME AXETILCEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2003-07-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2003-07-25bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A065135-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065135-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065135-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065135-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065135-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065135-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065135-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065135-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065135-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065135-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065135-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065135-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065135-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065135-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065135-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065135-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065135-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065135-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065135-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065135-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065135-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065135-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065135-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065135-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065135-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065135-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065135-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065135-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065135-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065135-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065135-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065135-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065135-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065135-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065135-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065135-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065135-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065135-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065135-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065135-002AB15aa47cf7b7d7…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime AxetilCEFUROXIME AXETILREMEDYREPACK INC.76cec54f-d167-4298-951b-5411a3c47f4a2026-08-05Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILRedpharm Drug56cb6f42-9ae1-38e7-e063-6294a90a3feb2026-07-31Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutions85cdd8d9-557e-4d15-855a-027e7809cf642026-05-14Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsd14d4184-3e29-43cd-8046-658699c70f032026-05-14Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILGolden State Medical Supply, Inc.bb7955fe-5111-1662-e053-2a95a90a85a12026-04-23Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals, Inc.4e4426a4-0ca9-dad5-e063-6294a90a5fdb2026-03-30Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.a84ac4ed-c268-4e9f-9df8-256e0a64cd162026-03-18Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsa940ba01-2b53-4947-9019-d3d8f4e9ad802026-01-23Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILAdvanced Rx of Tennessee, LLC48d96608-d3da-b512-e063-6294a90a07d52026-01-16Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILRedpharm Drug3744f28c-c7e1-259c-e063-6294a90a10ed2025-12-11Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af8f061-c0e1-3a1c-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af94304-8118-41c7-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsaa6685c1-51ed-466a-ae7f-89a82986a7b12025-10-08Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutions119c4d09-2324-498f-9318-1f8db49ad4b62025-10-08Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILAscend Laboratories, LLCdd11e4b9-7730-4d3a-81ca-16f15de097592025-10-03Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILNuCare Pharmaceuticals, Inc.3f92c452-18b4-5af8-e063-6394a90aaa532025-09-24Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILMajor Pharmaceuticals44e1fb4d-4b61-40da-9974-0bd2006eb8282025-09-12Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILAmerican Health Packagingf38418a7-dd90-4f20-b747-7ac086c530152025-08-06Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL
Cefuroxime AxetilCEFUROXIME AXETILPreferred Pharmaceuticals Inc.bc9200d2-4a6d-4847-ba85-8e9d378390de2025-07-31Warnings, Adverse reactionsName fallback
brand name: Cefuroxime Axetil
generic name: CEFUROXIME AXETIL
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.15cabe73-f39d-4798-a840-115fe94f8f962025-03-13Warnings, Adverse reactionsName fallback
brand name: Cefuroxime axetil
generic name: CEFUROXIME AXETIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-584cefuroxime axetilcefuroxime axetilPD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-785cefuroxime axetilcefuroxime axetilLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0798cefuroxime axetilcefuroxime axetilA-S Medication SolutionsANDACurrent
57297-302cefuroxime axetilcefuroxime axetilLUPIN LIMITEDANDACurrent
57297-303cefuroxime axetilcefuroxime axetilLUPIN LIMITEDANDACurrent
60429-656cefuroxime axetilcefuroxime axetilGolden State Medical Supply Inc.ANDACurrent
60429-656cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
60429-656cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
60429-657cefuroxime axetilcefuroxime axetilGolden State Medical Supply Inc.ANDACurrent
60429-657cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
60429-657cefuroxime axetilcefuroxime axetilGolden State Medical Supply, Inc.ANDACurrent
68180-302cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-302cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-302cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-303cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-303cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68180-303cefuroxime axetilcefuroxime axetilLupin Pharmaceuticals, Inc.ANDACurrent
68788-9700cefuroxime axetilcefuroxime axetilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9701cefuroxime axetilcefuroxime axetilPreferred Pharmaceuticals, Inc.ANDACurrent