Home NDC 0264-3114 Cefuroxime and Dextrose
Product NDC 0264-3114
11-digit product format 002643114
Labeler code 0264
Product ID 0264-3114_6874a295-7ec7-4822-9d04-4dd9932b4546
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFUROXIME AND DEXTROSE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA050780
Marketing category NDA
Marketing start 2001-02-21
Substance CEFUROXIME SODIUM
Active strength 1.5 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 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21
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 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION RLD 2001-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050780-001 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 750MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050780-002 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 2001-02-21 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 Cefuroxime and Dextrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFUROXIME SODIUM 1.5 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R8A7M9MY61 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665444 Internal RxNorm lookup 1665449 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 0264-3114-11 Cefuroxime and Dextrose 50 mL in 1 CONTAINER INJECTION, SOLUTION 50 16 0264-3114-11 Cefuroxime and Dextrose 24 in 1 CASE INJECTION, SOLUTION 24 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-3114 CEFUROXIME AND DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 16 Current NDC, Legacy NDC, 2 package rows 20201219_07170ee3-1a24-424f-a2a2-00bc92e98f85.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 0264-3114-11 00264311411 24 CONTAINER in 1 CASE (0264-3114-11) / 50 mL in 1 CONTAINER 24 container 2001-02-21 0000-00-00 No No Current