NDC 67046-1081-03 - Cefuroxime Axetil

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67046-1081
Requested NDC
67046-1081-03
Package NDCs from labels
67046-1081-3, 67046-1081-03
Manufacturer
Coupler LLC
Effective date
2025-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefuroxime Axetil - Coupler LLCCoupler LLC2025-01-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1081-3Cefuroxime Axetil30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1081CEFUROXIME AXETIL TABLET [COUPLER LLC]1Current NDC, 1 package rows20250125_2c3a502f-8e72-c4d2-e063-6394a90a6fa5.zip

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 reactionsExact identifier
application number: ANDA065308
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILRedpharm Drug56cb6f42-9ae1-38e7-e063-6294a90a3feb2026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutions85cdd8d9-557e-4d15-855a-027e7809cf642026-05-14Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsd14d4184-3e29-43cd-8046-658699c70f032026-05-14Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILGolden State Medical Supply, Inc.bb7955fe-5111-1662-e053-2a95a90a85a12026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals, Inc.4e4426a4-0ca9-dad5-e063-6294a90a5fdb2026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.a84ac4ed-c268-4e9f-9df8-256e0a64cd162026-03-18Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsa940ba01-2b53-4947-9019-d3d8f4e9ad802026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILAdvanced Rx of Tennessee, LLC48d96608-d3da-b512-e063-6294a90a07d52026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILRedpharm Drug3744f28c-c7e1-259c-e063-6294a90a10ed2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af8f061-c0e1-3a1c-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af94304-8118-41c7-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsaa6685c1-51ed-466a-ae7f-89a82986a7b12025-10-08Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutions119c4d09-2324-498f-9318-1f8db49ad4b62025-10-08Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILAscend Laboratories, LLCdd11e4b9-7730-4d3a-81ca-16f15de097592025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILNuCare Pharmaceuticals, Inc.3f92c452-18b4-5af8-e063-6394a90aaa532025-09-24Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILMajor Pharmaceuticals44e1fb4d-4b61-40da-9974-0bd2006eb8282025-09-12Warnings, Adverse reactionsExact identifier
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILAmerican Health Packagingf38418a7-dd90-4f20-b747-7ac086c530152025-08-06Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILPreferred Pharmaceuticals Inc.bc9200d2-4a6d-4847-ba85-8e9d378390de2025-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA065308
rxcui: 309098
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.15cabe73-f39d-4798-a840-115fe94f8f962025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 309098
unii: Z49QDT0J8Z

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.