Cefoxitin

Product NDC
66288-4100
11-digit product format
662884100
Labeler code
66288
Product ID
66288-4100_b137208d-8dfd-4133-94c2-7287866a5525
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefoxitin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
SAMSON MEDICAL TECHNOLOGIES LLC
Application
ANDA200938
Marketing category
ANDA
Marketing start
2016-03-01
Substance
CEFOXITIN SODIUM
Active strength
100 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
A200938-001CEFOXITIN IN PLASTIC CONTAINERCEFOXITIN SODIUMEQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16

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 UTC2026-02A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-163f01610625f2…
2019-09-15 20:21 UTC2019-09A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200938-001CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEPOWDER / INTRAVENOUS2015-11-16cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOXITIN SODIUM100 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
1739890Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea6dba56-5d9c-463a-b1d9-f7af5b602ed9Available 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
66288-4100-1Cefoxitin1 in 1 BAGINJECTION, POWDER, FOR SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66288-4100CEFOXITIN INJECTION, POWDER, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES LLC]3Current NDC, Legacy NDC, 1 package rows20201120_ea6dba56-5d9c-463a-b1d9-f7af5b602ed9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefoxitinCEFOXITINSAMSON MEDICAL TECHNOLOGIES LLCea6dba56-5d9c-463a-b1d9-f7af5b602ed92020-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200938
application number: ANDA200938
ndc (product): 66288-4100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739890cefOXitin 100 MG/ML Injectable SolutionPSNea6dba56-5d9c-463a-b1d9-f7af5b602ed93
1739890cefoxitin 100 MG/ML Injectable SolutionSCDea6dba56-5d9c-463a-b1d9-f7af5b602ed93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66288-4100-1662884100011 BAG in 1 BAG (66288-4100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG1 bag2016-03-010000-00-00NoNoCurrent