NDC 0143-9569-01 - Cefuroxime

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0143-9569
Requested NDC: 0143-9569-01
Package NDCs from labels: 0143-9569-01, 0143-9569-10
Manufacturer: Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date: 2022-02-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Cefuroxime - Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2022-02-16	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9569-01	Cefuroxime	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		5
0143-9569-10	Cefuroxime	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9569	CEFUROXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20220217_79f5cf6f-a5e2-49a2-9704-fa1bd21338c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9569-01	EA - Each	0143-9569	352610a4-7e19-4e08-af64-980597f5ce3d	1	2015-08-04
0143-9569-10	EA - Each	0143-9569	55cc1079-7314-4503-aa6c-1cda2a7b6dbf	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEFUROXIME SODIUM	ACTIVE INGREDIENT	R8A7M9MY61	CEFUROXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	1
CEFUROXIME	ACTIVE MOIETY	O1R9FJ93ED	CEFUROXIME INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime sodium	CEFUROXIME SODIUM	Sagent Pharmaceuticals	0a145288-733a-4966-b7ae-dc96eb103d8c	2025-03-27	Warnings, Adverse reactions	Exact identifier unii: R8A7M9MY61
Cefuroxime	CEFUROXIME	Hikma Pharmaceuticals USA Inc.	79f5cf6f-a5e2-49a2-9704-fa1bd21338c3	2022-02-16	Warnings, Adverse reactions	Exact identifier application number: ANDA065046 ndc (package): 0143-9569-01 ndc (package): 0143-9569-10 ndc (product): 0143-9569 ndc11 (package): 00143956901 rxcui: 309101 spl id: a44c47cd-1104-4275-b859-d7ed2af78b8e spl set id: 79f5cf6f-a5e2-49a2-9704-fa1bd21338c3 unii: R8A7M9MY61
Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	07170ee3-1a24-424f-a2a2-00bc92e98f85	2020-12-05	Warnings, Adverse reactions	Exact identifier unii: R8A7M9MY61
Cefuroxime	CEFUROXIME	Hikma Pharmaceuticals USA Inc.	65daa2aa-cc4a-4eba-b7dc-7a151806865a	2020-04-14	Warnings, Adverse reactions	Exact identifier application number: ANDA065046 rxcui: 309101 unii: R8A7M9MY61
Cefuroxime	CEFUROXIME	Hikma Pharmaceuticals USA Inc.	703cc338-c0b6-4a02-b8db-c27aeff181df	2020-04-08	Warnings, Adverse reactions	Exact identifier unii: R8A7M9MY61
Cefuroxime	CEFUROXIME	Hikma Pharmaceuticals USA Inc.	19902965-d2d6-433f-982d-0095014df4e8	2018-09-27	Warnings, Adverse reactions	Exact identifier unii: R8A7M9MY61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.