Home NDC 25021-109 Cefoxitin
Product NDC 25021-109
11-digit product format 250210109
Labeler code 25021
Product ID 25021-109_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 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-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.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-03-09 01:35 UTC 2022-03 A065414-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065414-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065414-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065414-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2009-06-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefoxitin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFOXITIN SODIUM 1 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-109-10 Cefoxitin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 10 25021-109-10 Cefoxitin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-109 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 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): 25021-109 Cefoxitin CEFOXITIN WG Critical Care, LLC 658a0dc6-6da5-44dc-94f2-1211619297f7 2023-10-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065414 application number: ANDA065414 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-109-10 25021010910 10 VIAL in 1 CARTON (25021-109-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2009-11-05 0000-00-00 No No Current