Application 065359

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 125MG BASE	No	No
002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 250MG BASE	No	No
003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 500MG BASE	No	No

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	Approval date
A065359-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15
A065359-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15
A065359-003	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065359-001	AB
A065359-002	AB
A065359-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065359-002	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065359-003	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2008-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065359-001	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET / ORAL	AB	2008-02-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065359-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065359-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065359-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065359-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065359-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065359-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065359-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065359-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065359-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065359-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065359-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065359-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065359-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065359-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065359-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065359-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065359-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065359-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065359-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065359-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065359-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065359-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065359-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065359-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065359-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065359-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065359-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065359-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065359-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065359-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065359-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065359-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065359-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065359-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065359-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065359-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065359-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065359-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065359-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065359-001	AB	1	`8072bd15b7f6…`

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 2 · 32 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	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	85cdd8d9-557e-4d15-855a-027e7809cf64	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	d14d4184-3e29-43cd-8046-658699c70f03	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Golden State Medical Supply, Inc.	bb7955fe-5111-1662-e053-2a95a90a85a1	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	4e4426a4-0ca9-dad5-e063-6294a90a5fdb	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	a84ac4ed-c268-4e9f-9df8-256e0a64cd16	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	REMEDYREPACK INC.	76cec54f-d167-4298-951b-5411a3c47f4a	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	a940ba01-2b53-4947-9019-d3d8f4e9ad80	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Advanced Rx of Tennessee, LLC	48d96608-d3da-b512-e063-6294a90a07d5	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Redpharm Drug	3744f28c-c7e1-259c-e063-6294a90a10ed	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af8f061-c0e1-3a1c-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af94304-8118-41c7-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	aa6685c1-51ed-466a-ae7f-89a82986a7b1	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	A-S Medication Solutions	119c4d09-2324-498f-9318-1f8db49ad4b6	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Ascend Laboratories, LLC	dd11e4b9-7730-4d3a-81ca-16f15de09759	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	3f92c452-18b4-5af8-e063-6394a90aaa53	2025-09-24	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	Major Pharmaceuticals	44e1fb4d-4b61-40da-9974-0bd2006eb828	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	American Health Packaging	f38418a7-dd90-4f20-b747-7ac086c53015	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL
Cefuroxime Axetil	CEFUROXIME AXETIL	Preferred Pharmaceuticals Inc.	bc9200d2-4a6d-4847-ba85-8e9d378390de	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime Axetil generic name: CEFUROXIME AXETIL
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	15cabe73-f39d-4798-a840-115fe94f8f96	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Cefuroxime axetil generic name: CEFUROXIME AXETIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66116-479	Cefuroxime Axetil	Cefuroxime Axetil	MedVantx, Inc.	ANDA	Current