NDC 55648-986-01 - CEFOTAXIME

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: 55648-986
Requested NDC: 55648-986-01
Package NDCs from labels: 55648-986-01, 55648-986-02, 55648-986-03, 55648-986-04
Manufacturer: WOCKHARDT LIMITED
Effective date: 2010-10-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
CEFOTAXIME - WOCKHARDT LIMITED	WOCKHARDT LIMITED	2010-10-19	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-986-02	2019-10-29	C162847	48780-1	960f7f55-d1d5-8e05-e053-dbdaa90a074a	Prescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
55648-986-03	2019-10-29	C162847	48780-1	960f7f55-d1d5-8e05-e053-dbdaa90a074a	Prescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
55648-986-04	2019-10-29	C162847	48780-1	960f7f55-d1d5-8e05-e053-dbdaa90a074a	Prescribing information Cefotaxime for Injection, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-986-01	CEFOTAXIME	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1	1
55648-986-01	CEFOTAXIME	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	10	1
55648-986-02	CEFOTAXIME	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	1
55648-986-03	CEFOTAXIME	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25	1
55648-986-04	CEFOTAXIME	50 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	50	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-986	CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]	1	Legacy NDC, 5 package rows	20101026_a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEFOTAXIME SODIUM	ACTIVE INGREDIENT	258J72S7TZ	CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]	1
CEFOTAXIME	ACTIVE MOIETY	N2GI8B1GK7	CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefotaxime	CEFOTAXIME INJECTION	SteriMax Inc.	8efe3bd0-c43a-2bd6-e053-2a95a90a92fa	2026-06-15		Exact identifier rxcui: 1656313 rxcui: 1656318 unii: 258J72S7TZ
Cefotaxime	CEFOTAXIME	Hikma Pharmaceuticals USA Inc.	ed23b6bc-32c7-4c50-a53d-313ae78e5623	2024-04-11	Warnings, Adverse reactions	Exact identifier rxcui: 309068 rxcui: 1656313 rxcui: 1656318 unii: 258J72S7TZ
Cefotaxime	CEFOTAXIME	Hikma Pharmaceuticals USA Inc.	ef1a6dc6-bc3d-4f09-8f92-7ff328f56561	2024-04-11	Warnings, Adverse reactions	Exact identifier unii: 258J72S7TZ
ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b			a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7	2010-10-19	Warnings, Adverse reactions	Exact identifier spl id: ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b spl set id: a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7

Reported adverse events (FAERS/openFDA)#

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