Cefuroxime Axetil

Product NDC: 67046-1081
11-digit product format: 670461081
Labeler code: 67046
Product ID: 67046-1081_2c3a51b0-6e4a-9ae0-e063-6394a90acc40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime Axetil
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA065308
Marketing category: ANDA
Marketing start: 2025-01-21
Substance: CEFUROXIME AXETIL
Active strength: 500 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-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.

Product history page 1 of 4 · 126 observed 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
2026-08-18 06:07:40	2026-07	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	RS	2006-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	RS	2006-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	RS	2006-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065308-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2006-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065308-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2006-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065308-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB		2006-03-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065308-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065308-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065308-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065308-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065308-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065308-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065308-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065308-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065308-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065308-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065308-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065308-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065308-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065308-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065308-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065308-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065308-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065308-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065308-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065308-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065308-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065308-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065308-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065308-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065308-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065308-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065308-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065308-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065308-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065308-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065308-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065308-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065308-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065308-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065308-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065308-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065308-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065308-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065308-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065308-001	AB	1	`1e350fbaab3a…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
2c3a502f-8e72-c4d2-e063-6394a90a6fa5	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
67046-1081-3	Cefuroxime Axetil	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1081	CEFUROXIME AXETIL TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250125_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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime Axetil	CEFUROXIME AXETIL	REMEDYREPACK INC.	76cec54f-d167-4298-951b-5411a3c47f4a	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065308 application number: ANDA065308
Cefuroxime Axetil	CEFUROXIME AXETIL	Redpharm Drug	56cb6f42-9ae1-38e7-e063-6294a90a3feb	2026-07-31	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	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 ndc (product): 67046-1081
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
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

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
309098	cefuroxime axetil 500 MG Oral Tablet	PSN	2c3a502f-8e72-c4d2-e063-6394a90a6fa5	1
309098	cefuroxime 500 MG Oral Tablet	SCD	2c3a502f-8e72-c4d2-e063-6394a90a6fa5	1
309098	cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet	SY	2c3a502f-8e72-c4d2-e063-6394a90a6fa5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1081-3	67046108103	30 TABLET in 1 BLISTER PACK (67046-1081-3)	30 tablet	2025-01-21	No	No	Current