CEFUROXIME AXETIL

Product NDC: 61919-044
Requested package NDC: 61919-044-20
11-digit product format: 619190044
Labeler code: 61919
Product ID: 61919-044_9c5b1bc4-fa6f-10c6-e053-2995a90a9e9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFUROXIME AXETIL
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA065308
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: CEFUROXIME AXETIL
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	61919-044	61919-044-20	I	Inactivated by FDA		2026-08-03

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
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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-044-20	2023-01-30	C162847	48780-1	f386c649-f05e-0266-e053-dadaa90a7c1a	CEFUROXIME AXETIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-044-20	CEFUROXIME AXETIL	20 in 1 BOTTLE	TABLET	20		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-044-20	EA - Each	61919-044	d65fe4c3-cb0a-4e0d-b710-fad98cd4baae	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFUROXIME AXETIL	ACTIVE INGREDIENT	Z49QDT0J8Z	CEFUROXIME AXETIL TABLET [DIRECT RX]	1
CEFUROXIME	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME AXETIL TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFUROXIME AXETIL TABLET [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFUROXIME AXETIL TABLET [DIRECT RX]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	CEFUROXIME AXETIL TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFUROXIME AXETIL TABLET [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFUROXIME AXETIL TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-044	CEFUROXIME AXETIL TABLET [DIRECT RX]	3	Legacy NDC, 1 package rows	20200118_82d6ef8a-29cc-4bfb-8801-fdb8fd6f1ff8.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	82d6ef8a-29cc-4bfb-8801-fdb8fd6f1ff8	3
309097	cefuroxime 250 MG Oral Tablet	SCD	82d6ef8a-29cc-4bfb-8801-fdb8fd6f1ff8	3
309097	cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet	SY	82d6ef8a-29cc-4bfb-8801-fdb8fd6f1ff8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-044-20	61919004420	20 TABLET in 1 BOTTLE (61919-044-20)	20 tablet	2015-01-01	0000-00-00	No	No	Current