Cefuroxime axetil

Product NDC: 52959-308
11-digit product format: 529590308
Labeler code: 52959
Product ID: 52959-308_14405431-115c-417b-918e-17a63bb6042a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime axetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA065496
Marketing category: ANDA
Marketing start: 2010-12-01
Marketing end: 0000-00-00
Substance: CEFUROXIME AXETIL
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52959-308		I	Inactivated by FDA		2026-08-17
excluded package	package	52959-308	52959-308-20	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-308-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-308-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-308-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-308-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-308-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-308-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-308-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-308-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-308-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-308-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-308-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-308-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-308-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-308-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-308-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-308-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-308-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-308-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-308-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-308-20	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52959-308-20	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	52959-308-20	`110d247fa046…`	`a55b01930146…`

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

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A065496-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065496-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065496-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065496-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065496-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065496-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065496-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065496-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065496-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065496-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065496-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065496-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065496-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065496-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065496-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065496-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065496-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065496-002	AB	1	`bb7c543d1eb4…`

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
52959-308-20	2019-11-13	C162847	48780-1	97449f38-c623-f6ea-e053-dbdaa90aa703	1bc56a86-735c-4787-826a-9bb59027fa09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-308-20	Cefuroxime axetil	20 in 1 BOTTLE	TABLET, FILM COATED	20		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Cefuroxime axetil	ACTIVE INGREDIENT	Z49QDT0J8Z	CEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
Cefuroxime	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-308	CEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 1 package rows	20111223_1bc56a86-735c-4787-826a-9bb59027fa09.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 · 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
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

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	1bc56a86-735c-4787-826a-9bb59027fa09	2
309097	cefuroxime 250 MG Oral Tablet	SCD	1bc56a86-735c-4787-826a-9bb59027fa09	2
309097	cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet	SY	1bc56a86-735c-4787-826a-9bb59027fa09	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-308-20	52959030820	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefuroxime - H.J. Harkins Company, Inc. \| Ascend Laboratories, LLC \| Alkem Laboratories Limited, Daman	H.J. Harkins Company, Inc. \| Ascend Laboratories, LLC \| Alkem Laboratories Limited, Daman	2011-12-22	Human Prescription Drug Label	2