Cefuroxime Axetil

Product NDC: 55648-920
11-digit product format: 556480920
Labeler code: 55648
Product ID: 55648-920_f4bea44f-32ac-431b-8909-e81bb02e65ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefuroxime Axetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wockhardt Limited
Application: ANDA065166
Marketing category: ANDA
Marketing start: 2005-07-29
Marketing end: 0000-00-00
Substance: CEFUROXIME AXETIL
Active strength: 125 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-920		I	Inactivated by FDA	2026-08-17
excluded package	package	55648-920	55648-920-01	I	Inactivated by FDA	2026-08-17
excluded package	package	55648-920	55648-920-02	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 2 · 66 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	55648-920-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-920-01	`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	55648-920-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-920-01	`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	55648-920-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-920-01	`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	55648-920-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-920-01	`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	55648-920-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-920-01	`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	55648-920-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-920-01	`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	55648-920-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-920-01	`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	55648-920-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-920-01	`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	55648-920-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-920-01	`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	55648-920-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-920-01	`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	55648-920-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-920-01	`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	55648-920-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-920-01	`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	55648-920-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-920-01	`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	55648-920-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-920-01	`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	55648-920-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-920-01	`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	55648-920-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-920-01	`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	55648-920-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-920-01	`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	55648-920-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-920-01	`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	55648-920-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-920-01	`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	55648-920-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-920-01	`e2bbac7714bc…`	`27bdfed8d636…`

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	Approval date
A065166-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29
A065166-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29
A065166-003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065166-001	AB
A065166-002	AB
A065166-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065166-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2005-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065166-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2005-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065166-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2005-07-29	`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	A065166-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065166-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065166-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065166-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065166-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065166-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065166-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065166-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065166-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065166-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065166-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065166-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065166-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065166-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065166-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065166-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065166-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065166-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065166-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065166-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065166-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065166-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065166-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065166-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065166-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065166-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065166-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065166-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065166-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065166-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065166-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065166-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065166-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065166-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065166-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065166-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065166-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065166-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065166-001	AB	1	`1e350fbaab3a…`

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
55648-920-01	2020-01-31	C162847	48780-1	9d75b9d0-546a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use cefuroxime axetil tablets safely and effectively. See full prescribing information for cefuroxime axetil tablets. CEFUROXIME AXETIL tablets, USP, for oral use Initial U.S. Approval: 1987
55648-920-02	2020-01-31	C162847	48780-1	9d75b9d0-546a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use cefuroxime axetil tablets safely and effectively. See full prescribing information for cefuroxime axetil tablets. CEFUROXIME AXETIL tablets, USP, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55648-920-01	Cefuroxime Axetil	20 in 1 BOTTLE	TABLET, FILM COATED	20		2
55648-920-02	Cefuroxime Axetil	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFUROXIME AXETIL	ACTIVE INGREDIENT	Z49QDT0J8Z	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
CEFUROXIME	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
SMCC	INACTIVE INGREDIENT	B357P1G1IF	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-920	CEFUROXIME AXETIL TABLET, FILM COATED [WOCKHARDT LIMITED]	2	Legacy NDC, 2 package rows	20160105_708b7a4d-ba1f-47b5-be4d-a01c2a7017ff.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	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309097	cefuroxime axetil 250 MG Oral Tablet	PSN	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309098	cefuroxime axetil 500 MG Oral Tablet	PSN	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309095	cefuroxime 125 MG Oral Tablet	SCD	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309097	cefuroxime 250 MG Oral Tablet	SCD	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309098	cefuroxime 500 MG Oral Tablet	SCD	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309095	cefuroxime (as cefuroxime axetil) 125 MG Oral Tablet	SY	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309097	cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet	SY	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2
309098	cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet	SY	708b7a4d-ba1f-47b5-be4d-a01c2a7017ff	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-920-01	55648092001	20 in 1 BOTTLE	Historical
55648-920-02	55648092002	60 in 1 BOTTLE	Historical