Cefuroxime Axetil

Product NDC: 65862-698
Requested package NDC: 65862-698-75
11-digit product format: 658620698
Labeler code: 65862
Product ID: 65862-698_5716a24a-653f-488a-bb44-85abffcbf92c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime Axetil
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065308
Marketing category: ANDA
Marketing start: 2006-03-29
Substance: CEFUROXIME AXETIL
Active strength: 125 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-698	65862-698-75	UNFINISHED	Active or certified unfinished drug listing		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065308-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29
A065308-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29
A065308-003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	RS	2006-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065308-001	AB
A065308-002	AB
A065308-003	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	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	RS	2006-03-29	`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	A065308-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065308-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A065308-003	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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime Axetil	CEFUROXIME AXETIL	Redpharm Drug	56cb6f42-9ae1-38e7-e063-6294a90a3feb	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	85cdd8d9-557e-4d15-855a-027e7809cf64	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	d14d4184-3e29-43cd-8046-658699c70f03	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	a84ac4ed-c268-4e9f-9df8-256e0a64cd16	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	REMEDYREPACK INC.	76cec54f-d167-4298-951b-5411a3c47f4a	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	a940ba01-2b53-4947-9019-d3d8f4e9ad80	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	aa6685c1-51ed-466a-ae7f-89a82986a7b1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	119c4d09-2324-498f-9318-1f8db49ad4b6	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	3f92c452-18b4-5af8-e063-6394a90aaa53	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	Preferred Pharmaceuticals Inc.	bc9200d2-4a6d-4847-ba85-8e9d378390de	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	Coupler LLC	2c619a79-6b69-b9fa-e063-6394a90a8f27	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	Coupler LLC	2c3a502f-8e72-c4d2-e063-6394a90a6fa5	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	NorthStar Rx LLC	fd79c41e-b0e9-47dc-a3ce-caacdc66bc96	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	Aurobindo Pharma Limited	faef39e9-d793-4191-a728-310f6fab759d	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308 ndc (product): 65862-698
Cefuroxime Axetil	CEFUROXIME AXETIL	Rising Pharma Holdings, Inc.	66f8d37f-aebc-4435-af80-dfd7b3770088	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	eb180b38-f8c8-4dbf-856a-347d3ebac857	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	bcf7870a-7e45-4ae1-a9b4-457e4781886a	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFUROXIME AXETIL	125 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309095	Internal RxNorm lookup
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
faef39e9-d793-4191-a728-310f6fab759d	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
65862-698-20	Cefuroxime Axetil	20 in 1 BOTTLE	TABLET	20		13
65862-698-60	Cefuroxime Axetil	60 in 1 BOTTLE	TABLET	60		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFUROXIME AXETIL	ACTIVE INGREDIENT	Z49QDT0J8Z	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
CEFUROXIME	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-698	CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]	13	Current NDC, Legacy NDC, 2 package rows	20240501_faef39e9-d793-4191-a728-310f6fab759d.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
309095	cefuroxime axetil 125 MG Oral Tablet	PSN	faef39e9-d793-4191-a728-310f6fab759d	13
309097	cefuroxime axetil 250 MG Oral Tablet	PSN	faef39e9-d793-4191-a728-310f6fab759d	13
309098	cefuroxime axetil 500 MG Oral Tablet	PSN	faef39e9-d793-4191-a728-310f6fab759d	13
309095	cefuroxime 125 MG Oral Tablet	SCD	faef39e9-d793-4191-a728-310f6fab759d	13
309097	cefuroxime 250 MG Oral Tablet	SCD	faef39e9-d793-4191-a728-310f6fab759d	13
309098	cefuroxime 500 MG Oral Tablet	SCD	faef39e9-d793-4191-a728-310f6fab759d	13
309095	cefuroxime (as cefuroxime axetil) 125 MG Oral Tablet	SY	faef39e9-d793-4191-a728-310f6fab759d	13
309097	cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet	SY	faef39e9-d793-4191-a728-310f6fab759d	13
309098	cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet	SY	faef39e9-d793-4191-a728-310f6fab759d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-698-75	65862069875	7500 TABLET in 1 BAG (65862-698-75)	7500 tablet	29-MAR-06	Current