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 42.

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 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050780-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050780-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050780-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050780-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050780-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050780-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050780-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050780-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050780-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050780-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050780-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050780-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050780-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050780-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050780-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050780-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050780-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050780-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050780-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050780-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050780-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050780-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050780-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050780-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050780-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050780-002	AP	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050780-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050780-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050780-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050780-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050780-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050780-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050780-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050780-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050780-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050780-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050780-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050780-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050780-002	AP	1	`cb3db0bc1861…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
07170ee3-1a24-424f-a2a2-00bc92e98f85	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-3114-11	EA - Each	0264-3114	b43e5214-885e-46cc-8f7b-063c0efca1b0	1	2012-07-24

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	07170ee3-1a24-424f-a2a2-00bc92e98f85	2020-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050780 application number: NDA050780 ndc (product): 0264-3114

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R8A7M9MY61	CEFUROXIME SODIUM	56238-63-2	CEFUROXIME SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665444	cefuroxime 1.5 GM Injection	PSN	07170ee3-1a24-424f-a2a2-00bc92e98f85	16
1665449	cefuroxime 750 MG Injection	PSN	07170ee3-1a24-424f-a2a2-00bc92e98f85	16
1665444	cefuroxime 1500 MG Injection	SCD	07170ee3-1a24-424f-a2a2-00bc92e98f85	16
1665449	cefuroxime 750 MG Injection	SCD	07170ee3-1a24-424f-a2a2-00bc92e98f85	16
1665444	cefuroxime 1.5 GM Injection	SY	07170ee3-1a24-424f-a2a2-00bc92e98f85	16

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CefUROXime for Injection USP and Dextrose Injection USP	B. Braun Medical Inc.	2020-12-05	HUMAN PRESCRIPTION DRUG LABEL	16