Home NDC 0143-9878 Cefoxitin
Product NDC 0143-9878
11-digit product format 001439878
Labeler code 0143
Product ID 0143-9878_4638263b-1c03-4a32-ba82-70270cf42490
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefoxitin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065238
Marketing category ANDA
Marketing start 2010-03-12
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 A065238-001 CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 A065238-002 CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12
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 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065238-001 CEFOXITIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065238-002 CEFOXITIN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2010-03-12 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 0143-9878-01 Cefoxitin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 9 0143-9878-25 Cefoxitin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9878 CEFOXITIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240413_d2c449b9-5624-4166-95b1-d7813b3d0445.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 0143-9878-01 00143987801 1 in 1 VIAL Historical 0143-9878-25 00143987825 25 VIAL in 1 CARTON (0143-9878-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9878-01) 25 vial 2010-03-12 0000-00-00 No No Current