Cefuroxime axetil

Product NDC: 51407-334
11-digit product format: 514070334
Labeler code: 51407
Product ID: 51407-334_502429f5-1f55-2030-e063-6394a90aef14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime axetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA065496
Marketing category: ANDA
Marketing start: 2010-06-07
Substance: CEFUROXIME AXETIL
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065496-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2010-06-07
A065496-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2010-06-07

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2010-06-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2010-06-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A065496-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065496-002	AB	1	`a50c72e98297…`

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime axetil	CEFUROXIME AXETIL	Golden State Medical Supply, Inc.	bb7955fe-5111-1662-e053-2a95a90a85a1	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 51407-334
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	4e4426a4-0ca9-dad5-e063-6294a90a5fdb	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Advanced Rx of Tennessee, LLC	48d96608-d3da-b512-e063-6294a90a07d5	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Redpharm Drug	3744f28c-c7e1-259c-e063-6294a90a10ed	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af8f061-c0e1-3a1c-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af94304-8118-41c7-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Ascend Laboratories, LLC	dd11e4b9-7730-4d3a-81ca-16f15de09759	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Major Pharmaceuticals	44e1fb4d-4b61-40da-9974-0bd2006eb828	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	American Health Packaging	f38418a7-dd90-4f20-b747-7ac086c53015	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	15cabe73-f39d-4798-a840-115fe94f8f96	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	A-S Medication Solutions	84593261-838c-433a-8d9d-1d37b11058da	2024-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	83476d51-be74-748b-e053-2a91aa0a3d36	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	8c3c1c85-cbce-66e2-e053-2a95a90a94fe	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	A-S Medication Solutions	c89e8f4d-96c0-44c6-906a-b803141920b1	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Proficient Rx LP	e9a020ec-e446-469a-b1d1-07e82eefa305	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496

Additional Listing Data#

Finished product: Yes
Brand name base: Cefuroxime axetil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFUROXIME AXETIL	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Z49QDT0J8Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309097	Internal RxNorm lookup
309098	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
bb7955fe-5111-1662-e053-2a95a90a85a1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51407-334-20	Cefuroxime axetil	20 in 1 BOTTLE	TABLET, FILM COATED	20		7
51407-334-60	Cefuroxime axetil	60 in 1 BOTTLE	TABLET, FILM COATED	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-334-20	EA - Each	51407-334	96d43b42-d006-44ce-93fa-d2a2f81f72ab	1	2021-03-02
51407-334-60	EA - Each	51407-334	2d441133-2b69-4b9c-9c83-e16cb9b16936	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-334	CEFUROXIME AXETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240504_bb7955fe-5111-1662-e053-2a95a90a85a1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z49QDT0J8Z	CEFUROXIME AXETIL	64544-07-6	CEFUROXIME AXETIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309097	cefuroxime axetil 250 MG Oral Tablet	PSN	bb7955fe-5111-1662-e053-2a95a90a85a1	7
309098	cefuroxime axetil 500 MG Oral Tablet	PSN	bb7955fe-5111-1662-e053-2a95a90a85a1	7
309097	cefuroxime 250 MG Oral Tablet	SCD	bb7955fe-5111-1662-e053-2a95a90a85a1	7
309098	cefuroxime 500 MG Oral Tablet	SCD	bb7955fe-5111-1662-e053-2a95a90a85a1	7
309097	cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet	SY	bb7955fe-5111-1662-e053-2a95a90a85a1	7
309098	cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet	SY	bb7955fe-5111-1662-e053-2a95a90a85a1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-334-20	51407033420	20 TABLET, FILM COATED in 1 BOTTLE (51407-334-20)	2021-01-29	0000-00-00	No	No	Current
51407-334-60	51407033460	60 TABLET, FILM COATED in 1 BOTTLE (51407-334-60)	2021-01-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefuroxime axetil	Golden State Medical Supply, Inc. \| Alkem Laboratories Limited	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	7