Home NDC 0143-9876-10 Cefoxitin
Product NDC 0143-9876
Requested package NDC 0143-9876-10
11-digit product format 001439876
Labeler code 0143
Product ID 0143-9876_3de36693-e566-4f2a-b9fe-8b777b275fa4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefoxitin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065239
Marketing category ANDA
Marketing start 2010-02-26
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0143-9876 0143-9876-10 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0143-9876 0143-9876-10 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0143-9876 0143-9876-10 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065239-001 CEFOXITIN CEFOXITIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065239-001 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 2 · 42 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 2026-08-18 06:07:40 2026-07 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065239-001 CEFOXITIN EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309072 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9876-01 Cefoxitin 1 in 1 BOTTLE INJECTION, POWDER, FOR SOLUTION 1 13 0143-9876-10 Cefoxitin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9876 CEFOXITIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250305_6a4a2afa-4f00-41d4-bd6d-baa0a95f6929.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.
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 0143-9876-10 00143987610 10 BOTTLE in 1 CARTON (0143-9876-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE (0143-9876-01) 10 bottle 2010-02-26 0000-00-00 No No Current