Home NDC 0264-3123 Cefoxitin and Dextrose
Product NDC 0264-3123
11-digit product format 002643123
Labeler code 0264
Product ID 0264-3123_0cca0e6a-3047-4142-af33-d9b98efe85b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFOXITIN SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA065214
Marketing category NDA
Marketing start 2006-03-10
Substance CEFOXITIN SODIUM
Active strength 1 g/50mL
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 43 .
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 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10
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 · 86 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 2026-09-14 22:38:34 2026-08 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N065214-001 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N065214-002 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2006-03-10 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cefoxitin and Dextrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFOXITIN SODIUM 1 g/50mL
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 0264-3123-11 Cefoxitin and Dextrose 50 mL in 1 CONTAINER INJECTION, SOLUTION 50 23 0264-3123-11 Cefoxitin and Dextrose 24 in 1 CASE INJECTION, SOLUTION 24 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-3123 CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 23 Current NDC, Legacy NDC, 2 package rows 20221027_6c7e9485-1ede-411c-8c46-911439332864.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 0264-3123-11 00264312311 24 CONTAINER in 1 CASE (0264-3123-11) / 50 mL in 1 CONTAINER 24 container 2006-03-10 0000-00-00 No No Current