FDA.reportPublic FDA data

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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065135-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORAL2003-07-25a50c72e98297…
2026-08-01 22:54:322026-06A065135-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORAL2003-07-25a50c72e98297…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime AxetilCEFUROXIME AXETILRedpharm Drug56cb6f42-9ae1-38e7-e063-6294a90a3feb2026-07-17Warnings, 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 AXETILREMEDYREPACK INC.76cec54f-d167-4298-951b-5411a3c47f4a2026-02-13Warnings, 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