Application 050581

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20
N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20
N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20
N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOXITIN SODIUM	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050581-001	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050581-002	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050581-003	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050581-004	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 40MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1984-09-20	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefoxitin	CEFOXITIN SODIUM	Fresenius Kabi USA, LLC	2a9d1e7b-96ee-4e6c-a1e8-47b76b924422	2023-07-10	Warnings, Adverse reactions	Name fallback generic name: CEFOXITIN SODIUM
Cefoxitin	CEFOXITIN SODIUM	Fresenius Kabi USA, LLC	d02170ff-65aa-48b8-a922-94271c46ffa7	2022-09-23	Warnings, Adverse reactions	Name fallback generic name: CEFOXITIN SODIUM
Cefoxitin and Dextrose	CEFOXITIN SODIUM	B. Braun Medical Inc.	6c7e9485-1ede-411c-8c46-911439332864	2019-07-29	Warnings, Adverse reactions	Name fallback generic name: CEFOXITIN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42650	SUPPL	2004-08-10