Cefoxitin

Product NDC
44567-245
11-digit product format
445670245
Labeler code
44567
Product ID
44567-245_f8445b8a-621d-4fd1-a8b6-de87d6f23080
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefoxitin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065414
Marketing category
ANDA
Marketing start
2017-07-10
Substance
CEFOXITIN SODIUM
Active strength
1 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065414-001CEFOXITINCEFOXITIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12
A065414-002CEFOXITINCEFOXITIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12

Therapeutic equivalence codes#

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

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

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065414-001CEFOXITINEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A065414-002CEFOXITINEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS2009-06-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065414-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065414-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065414-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065414-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065414-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065414-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065414-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065414-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065414-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065414-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065414-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065414-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065414-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065414-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065414-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065414-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065414-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065414-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065414-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065414-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065414-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065414-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065414-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065414-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065414-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065414-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065414-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065414-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065414-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065414-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065414-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065414-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065414-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065414-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065414-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065414-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065414-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065414-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065414-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065414-002AP1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOXITIN SODIUM1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q68050H03TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91ac4c14-8dd8-4efe-a462-d1c488a6184fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
674c093f-2e56-4442-b936-d876c9ac5966Product name120160111
33228014-863e-d9a4-2fc1-b5fe1bf2d490Product name120140508
cd1ea622-6dd0-ac04-3600-f4b6f14160ccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-245-25Cefoxitin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION17
44567-245-25Cefoxitin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION257
44567-245-85Cefoxitin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION257
44567-245-85Cefoxitin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-245-25EA - Each44567-245c6940918-e19c-4833-ba5c-3ff55f3b667d12015-07-20
44567-245-85EA - Each44567-245cc2f18c3-bed4-4324-95e3-f26f4d3f1a0c12018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOXITIN SODIUMACTIVE INGREDIENTQ68050H03TCEFOXITIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]1
CEFOXITINACTIVE MOIETY6OEV9DX57YCEFOXITIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-245CEFOXITIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]7Current NDC, Legacy NDC, 2 package rows20231019_658a0dc6-6da5-44dc-94f2-1211619297f7.zip
44567-245CEFOXITIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6Current NDC, Legacy NDC, 2 package rows20241206_91ac4c14-8dd8-4efe-a462-d1c488a6184f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefoxitinCEFOXITINWG Critical Care, LLC91ac4c14-8dd8-4efe-a462-d1c488a6184f2025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065414
application number: ANDA065414
ndc (product): 44567-245
CefoxitinCEFOXITINSagent Pharmaceuticalsb272ef9c-4d83-4ee2-b9cc-477440822cca2024-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065414
application number: ANDA065414
CefoxitinCEFOXITINWG Critical Care, LLC658a0dc6-6da5-44dc-94f2-1211619297f72023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065414
application number: ANDA065414
ndc (product): 44567-245
CefoxitinCEFOXITIN SODIUMFresenius Kabi USA, LLC2a9d1e7b-96ee-4e6c-a1e8-47b76b9244222023-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065414
application number: ANDA065414
CefoxitinCEFOXITIN SODIUMFresenius Kabi USA, LLCd02170ff-65aa-48b8-a922-94271c46ffa72022-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065414
application number: ANDA065414

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665102cefOXitin 1 GM InjectionPSN658a0dc6-6da5-44dc-94f2-1211619297f77
1665102cefOXitin 1 GM InjectionPSN91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665107cefOXitin 2 GM InjectionPSN658a0dc6-6da5-44dc-94f2-1211619297f77
1665107cefOXitin 2 GM InjectionPSN91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665102cefoxitin 1000 MG InjectionSCD658a0dc6-6da5-44dc-94f2-1211619297f77
1665102cefoxitin 1000 MG InjectionSCD91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665107cefoxitin 2000 MG InjectionSCD658a0dc6-6da5-44dc-94f2-1211619297f77
1665107cefoxitin 2000 MG InjectionSCD91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665102cefoxitin (as cefoxitin sodium) 1000 MG InjectionSY658a0dc6-6da5-44dc-94f2-1211619297f77
1665102cefoxitin (as cefoxitin sodium) 1000 MG InjectionSY91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665107cefoxitin (as cefoxitin sodium) 2000 MG InjectionSY658a0dc6-6da5-44dc-94f2-1211619297f77
1665107cefoxitin (as cefoxitin sodium) 2000 MG InjectionSY91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665102cefoxitin 1 GM InjectionSY658a0dc6-6da5-44dc-94f2-1211619297f77
1665102cefoxitin 1 GM InjectionSY91ac4c14-8dd8-4efe-a462-d1c488a6184f7
1665107cefoxitin 2 GM InjectionSY658a0dc6-6da5-44dc-94f2-1211619297f77
1665107cefoxitin 2 GM InjectionSY91ac4c14-8dd8-4efe-a462-d1c488a6184f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-245-254456702452525 VIAL in 1 CARTON (44567-245-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2015-02-180000-00-00NoNoCurrent
44567-245-854456702458525 VIAL in 1 CARTON (44567-245-85) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL25 vial2017-07-100000-00-00NoNoCurrent