Cefoxitin

Product NDC: 25021-110
11-digit product format: 250210110
Labeler code: 25021
Product ID: 25021-110_b43cf6e8-a0e4-4f66-9559-6fcc65c40532
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefoxitin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA065414
Marketing category: ANDA
Marketing start: 2009-11-05
Substance: CEFOXITIN SODIUM
Active strength: 2 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065414-001	CEFOXITIN	CEFOXITIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12
A065414-002	CEFOXITIN	CEFOXITIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065414-001	AP
A065414-002	AP

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 · 86 observed 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
2026-09-14 22:38:34	2026-08	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065414-001	CEFOXITIN	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065414-002	CEFOXITIN	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065414-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065414-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065414-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065414-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065414-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065414-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065414-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065414-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065414-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065414-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065414-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065414-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065414-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065414-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065414-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065414-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065414-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065414-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065414-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065414-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065414-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065414-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065414-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065414-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065414-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065414-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065414-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065414-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065414-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cefoxitin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFOXITIN SODIUM	2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q68050H03T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665102	Internal RxNorm lookup
1665107	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b272ef9c-4d83-4ee2-b9cc-477440822cca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
674c093f-2e56-4442-b936-d876c9ac5966	Product name	1	20160111
33228014-863e-d9a4-2fc1-b5fe1bf2d490	Product name	1	20140508
cd1ea622-6dd0-ac04-3600-f4b6f14160cc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25021-110-20	Cefoxitin	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		10
25021-110-20	Cefoxitin	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-110-20	EA - Each	25021-110	8b90ac47-ac99-488a-a15f-a13aa0870faa	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
cefoxitin sodium	ACTIVE INGREDIENT	Q68050H03T	CEFOXITIN (CEFOXITIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3
cefoxitin	ACTIVE MOIETY	6OEV9DX57Y	CEFOXITIN (CEFOXITIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-110	CEFOXITIN INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]	10	Current NDC, Legacy NDC, 2 package rows	20240105_b272ef9c-4d83-4ee2-b9cc-477440822cca.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefoxitin	CEFOXITIN	WG Critical Care, LLC	658a0dc6-6da5-44dc-94f2-1211619297f7	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414
Cefoxitin	CEFOXITIN	WG Critical Care, LLC	91ac4c14-8dd8-4efe-a462-d1c488a6184f	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414
Cefoxitin	CEFOXITIN	Sagent Pharmaceuticals	b272ef9c-4d83-4ee2-b9cc-477440822cca	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414 ndc (product): 25021-110
Cefoxitin	CEFOXITIN SODIUM	Fresenius Kabi USA, LLC	2a9d1e7b-96ee-4e6c-a1e8-47b76b924422	2023-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414
Cefoxitin	CEFOXITIN SODIUM	Fresenius Kabi USA, LLC	d02170ff-65aa-48b8-a922-94271c46ffa7	2022-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065414 application number: ANDA065414

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q68050H03T	CEFOXITIN SODIUM	33564-30-6	CEFOXITIN SODIUM
6OEV9DX57Y	CEFOXITIN	35607-66-0	cefoxitin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665102	cefOXitin 1 GM Injection	PSN	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665107	cefOXitin 2 GM Injection	PSN	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665102	cefoxitin 1000 MG Injection	SCD	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665107	cefoxitin 2000 MG Injection	SCD	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665102	cefoxitin (as cefoxitin sodium) 1000 MG Injection	SY	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665107	cefoxitin (as cefoxitin sodium) 2000 MG Injection	SY	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665102	cefoxitin 1 GM Injection	SY	b272ef9c-4d83-4ee2-b9cc-477440822cca	10
1665107	cefoxitin 2 GM Injection	SY	b272ef9c-4d83-4ee2-b9cc-477440822cca	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-110-20	25021011020	10 VIAL in 1 CARTON (25021-110-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL	10 vial	2009-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFOXITIN FOR INJECTION, USP (For Intravenous Use)	Sagent Pharmaceuticals	2024-01-03	HUMAN PRESCRIPTION DRUG LABEL	10