Cefuroxime Axetil

Product NDC
50090-7095
11-digit product format
500907095
Labeler code
50090
Product ID
50090-7095_89489a3f-de80-46af-b677-cc599a257e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065308-001CEFUROXIME AXETILCEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29
A065308-002CEFUROXIME AXETILCEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29
A065308-003CEFUROXIME AXETILCEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2006-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065308-001AB
A065308-002AB
A065308-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2006-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2006-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALABRS2006-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065308-002CEFUROXIME AXETILEQ 250MG BASETABLET / ORALAB2006-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065308-003CEFUROXIME AXETILEQ 500MG BASETABLET / ORALAB2006-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065308-001CEFUROXIME AXETILEQ 125MG BASETABLET / ORALAB2006-03-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065308-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065308-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065308-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065308-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065308-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065308-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065308-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065308-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065308-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065308-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065308-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065308-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065308-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065308-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065308-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065308-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065308-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065308-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065308-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065308-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065308-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065308-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065308-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065308-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065308-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065308-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065308-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065308-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065308-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065308-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065308-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065308-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065308-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065308-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065308-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065308-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065308-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065308-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065308-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065308-001AB11e350fbaab3a…

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
eb180b38-f8c8-4dbf-856a-347d3ebac857Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7095-0Cefuroxime Axetil20 in 1 BOTTLETABLET201
50090-7095-3Cefuroxime Axetil14 in 1 BOTTLETABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7095-0EA - Each50090-70958f113515-c181-4a7a-b22e-ee3f74eb214112024-04-05
50090-7095-3EA - Each50090-7095b9042297-bace-477f-b70d-5e73fd6d7bf512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7095CEFUROXIME AXETIL TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240229_eb180b38-f8c8-4dbf-856a-347d3ebac857.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 · 17 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 applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILRedpharm Drug56cb6f42-9ae1-38e7-e063-6294a90a3feb2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutions85cdd8d9-557e-4d15-855a-027e7809cf642026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsd14d4184-3e29-43cd-8046-658699c70f032026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.a84ac4ed-c268-4e9f-9df8-256e0a64cd162026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsa940ba01-2b53-4947-9019-d3d8f4e9ad802026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsaa6685c1-51ed-466a-ae7f-89a82986a7b12025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutions119c4d09-2324-498f-9318-1f8db49ad4b62025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILNuCare Pharmaceuticals, Inc.3f92c452-18b4-5af8-e063-6394a90aaa532025-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILPreferred Pharmaceuticals Inc.bc9200d2-4a6d-4847-ba85-8e9d378390de2025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILCoupler LLC2c619a79-6b69-b9fa-e063-6394a90a8f272025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILCoupler LLC2c3a502f-8e72-c4d2-e063-6394a90a6fa52025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILNorthStar Rx LLCfd79c41e-b0e9-47dc-a3ce-caacdc66bc962024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILAurobindo Pharma Limitedfaef39e9-d793-4191-a728-310f6fab759d2024-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILRising Pharma Holdings, Inc.66f8d37f-aebc-4435-af80-dfd7b37700882024-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionseb180b38-f8c8-4dbf-856a-347d3ebac8572024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308
ndc (product): 50090-7095
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsbcf7870a-7e45-4ae1-a9b4-457e4781886a2024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065308
application number: ANDA065308

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNeb180b38-f8c8-4dbf-856a-347d3ebac8571
309097cefuroxime 250 MG Oral TabletSCDeb180b38-f8c8-4dbf-856a-347d3ebac8571
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYeb180b38-f8c8-4dbf-856a-347d3ebac8571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7095-05009070950020 TABLET in 1 BOTTLE (50090-7095-0) 20 tablet2024-02-27NoNoCurrent
50090-7095-35009070950314 TABLET in 1 BOTTLE (50090-7095-3) 14 tablet2024-02-20NoNoCurrent