Cefoxitin

Product NDC
44567-247
Requested package NDC
44567-247-10
11-digit product format
445670247
Labeler code
44567
Product ID
44567-247_eaa65075-3ed9-4a2c-9aa5-2f24a34bf5b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefoxitin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065415
Marketing category
ANDA
Marketing start
2013-10-01
Substance
CEFOXITIN SODIUM
Active strength
10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065415-001CEFOXITINCEFOXITIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065415-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-193f01610625f2…
2019-09-15 20:21 UTC2019-09A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065415-001CEFOXITINEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2010-05-19cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065415-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065415-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065415-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065415-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065415-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065415-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065415-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065415-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065415-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065415-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065415-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065415-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065415-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065415-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065415-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065415-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065415-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065415-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065415-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065415-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065415-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A065415-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065415-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065415-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065415-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A065415-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065415-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065415-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065415-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065415-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065415-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065415-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065415-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065415-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065415-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065415-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065415-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065415-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065415-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065415-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOXITIN SODIUM10 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5288962-caee-4771-8229-df9cdefcfa67Available 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
44567-247-10Cefoxitin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
44567-247-10Cefoxitin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-247-10EA - Each44567-247cd481784-09ca-4a4b-87a0-929cb9516e4b12015-07-20

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
44567-247CEFOXITIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6Current NDC, Legacy NDC, 2 package rows20231017_f5288962-caee-4771-8229-df9cdefcfa67.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefoxitinCEFOXITINWG Critical Care, LLCf5288962-caee-4771-8229-df9cdefcfa672023-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065415
application number: ANDA065415
ndc (package): 44567-247-10
ndc (product): 44567-247
ndc11 (package): 44567024710
CefoxitinCEFOXITINSagent Pharmaceuticals4c6f7665-204f-6c69-7669-61204d756e6e2020-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065415
application number: ANDA065415

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309072cefOXitin 200 MG/ML Injectable SolutionPSNf5288962-caee-4771-8229-df9cdefcfa676
309072cefoxitin 200 MG/ML Injectable SolutionSCDf5288962-caee-4771-8229-df9cdefcfa676
309072cefoxitin (as cefoxitin sodium) 200 MG/ML Injectable SolutionSYf5288962-caee-4771-8229-df9cdefcfa676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
44567-247-104456702471010 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-247-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE2013-10-010000-00-00NoNoCurrent