NDC 68083-351-01 - Ertapenem

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: 68083-351
Requested NDC: 68083-351-01
Package NDCs from labels: 68083-351-01, 68083-351-10
Manufacturer: Gland Pharma Limited
Effective date: 2022-04-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ertapenem - Gland Pharma Limited	Gland Pharma Limited	2022-04-12	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-351-01	Ertapenem	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		8
68083-351-10	Ertapenem	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-351	ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20220414_f74cca2f-e775-4580-acae-3a0c47dd24d9.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 12 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM BICARBONATE	SODIUM BICARBONATE	Richmond Pharmaceuticals, Inc.	fa10d93d-b3ed-4675-a117-f573d9e72bca	2017-10-30	Warnings	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	Exela Pharma Sciences, LLC	e9698a4f-1a95-4f28-a945-e8009d1d6dd4	2017-09-27	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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