Cefuroxime axetil

Product NDC
68071-4947
11-digit product format
680714947
Labeler code
68071
Product ID
68071-4947_1b2e322e-13be-c58d-e063-6394a90a2829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Substance
CEFUROXIME AXETIL
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4947-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4947-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4947-21332a3947898…d4bfe170f9cd…

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
A065496-001CEFUROXIME AXETILCEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07
A065496-002CEFUROXIME AXETILCEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065496-001AB
A065496-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07caaa826d4ba7…
2026-08-18 06:07:402026-07A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065496-001CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2010-06-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065496-002CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2010-06-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065496-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065496-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065496-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065496-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065496-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065496-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065496-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065496-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065496-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065496-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065496-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065496-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065496-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065496-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065496-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065496-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065496-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065496-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065496-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065496-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065496-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065496-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065496-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065496-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065496-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065496-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065496-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065496-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065496-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065496-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065496-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065496-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065496-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065496-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065496-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065496-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065496-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065496-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065496-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065496-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime axetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME AXETIL250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z49QDT0J8ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309097Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c3c1c85-cbce-66e2-e053-2a95a90a94feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4947-2Cefuroxime axetil2 in 1 BOTTLETABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4947CEFUROXIME AXETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240629_8c3c1c85-cbce-66e2-e053-2a95a90a94fe.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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime axetilCEFUROXIME AXETILGolden State Medical Supply, Inc.bb7955fe-5111-1662-e053-2a95a90a85a12026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals, Inc.4e4426a4-0ca9-dad5-e063-6294a90a5fdb2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILAdvanced Rx of Tennessee, LLC48d96608-d3da-b512-e063-6294a90a07d52026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILRedpharm Drug3744f28c-c7e1-259c-e063-6294a90a10ed2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af8f061-c0e1-3a1c-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af94304-8118-41c7-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILAscend Laboratories, LLCdd11e4b9-7730-4d3a-81ca-16f15de097592025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILMajor Pharmaceuticals44e1fb4d-4b61-40da-9974-0bd2006eb8282025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILAmerican Health Packagingf38418a7-dd90-4f20-b747-7ac086c530152025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.15cabe73-f39d-4798-a840-115fe94f8f962025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILA-S Medication Solutions84593261-838c-433a-8d9d-1d37b11058da2024-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals,Inc.83476d51-be74-748b-e053-2a91aa0a3d362024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals,Inc.8c3c1c85-cbce-66e2-e053-2a95a90a94fe2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
ndc (product): 68071-4947
Cefuroxime axetilCEFUROXIME AXETILA-S Medication Solutionsc89e8f4d-96c0-44c6-906a-b803141920b12024-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496
Cefuroxime axetilCEFUROXIME AXETILProficient Rx LPe9a020ec-e446-469a-b1d1-07e82eefa3052023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065496
application number: ANDA065496

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime 250 MG Oral TabletSCD8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY8c3c1c85-cbce-66e2-e053-2a95a90a94fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4947-2680714947022 TABLET, FILM COATED in 1 BOTTLE (68071-4947-2) 2019-06-260000-00-00NoNoCurrent