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 11 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	APNAR PHARMA LP	e206c240-55c2-2d00-e053-2a95a90a1779	2023-10-21	Boxed warning, Warnings	Exact identifier unii: 8MDF5V39QO
Omeprazole/Sodium Bicarbonate	OMEPRAZOLE	Strides Pharma Science Limited	cf6d293e-d70d-443e-8292-d693e93aab55	2023-09-21	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	OMNIVIUM PHARMACEUTICALS LLC.	aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc	2023-08-10	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	c6b5f808-4a49-1303-9711-badb022ecd70	2023-07-19	Warnings	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	A-S Medication Solutions	619cb558-84e5-43ea-91e9-28c764f9f9c0	2023-06-21	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	b620938d-ab2d-0934-e053-2a95a90a8483	2023-05-23	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	d1636b56-ad83-4439-e053-2a95a90a135e	2023-05-02	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	Novel Laboratories, Inc.	29d821ff-389c-41fb-8a27-89bd3f022b82	2023-02-08	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Omeprazole, Sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Guardian Drug Company	e5c6c2cf-fb3b-456a-a0a0-be396d6f8319	2022-11-08	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Ertapenem	ERTAPENEM SODIUM	Fresenius Kabi USA, LLC	666c9f33-ea9e-4667-b8bd-f8b1b6b6be51	2022-11-08	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0
ertapenem	ERTAPENEM	WG Critical Care, LLC	cf3cfa6b-211c-452b-b18b-e462b21e6909	2022-08-31	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0
Ertapenem	ERTAPENEM SODIUM	Gland Pharma Limited	f74cca2f-e775-4580-acae-3a0c47dd24d9	2022-04-12	Warnings, Adverse reactions	Exact identifier application number: ANDA212040 ndc (package): 68083-351-01 ndc (package): 68083-351-10 ndc (product): 68083-351 ndc11 (package): 68083035101 rxcui: 1734683 spl id: 71422270-6a76-40e5-bd89-643b8b2fafd5 spl set id: f74cca2f-e775-4580-acae-3a0c47dd24d9 unii: 2T90KE67L0
Sodium Bicarbonate	SODIUM BICARBONATE	International Medication Systems, Limited	77698221-a01d-4568-a7bc-d3d4e982875d	2021-12-15	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
8.4% SODIUM BICARBONATE	8.4% SODIUM BICARBONATE	HF Acquisition Co. LLC, DBA HealthFirst	74d8bb7a-9e7a-105f-e053-2a91aa0aec92	2021-05-03	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
ERTAPENEM SODIUM	ERTAPENEM	Dr.Reddys Laboratories Inc.,	32d9f095-ca39-7e22-6264-b54f2daaee57	2021-04-30	Warnings, Adverse reactions	Exact identifier application number: ANDA212040 rxcui: 1734683 unii: 2T90KE67L0
SODIUM BICARBONATE	SODIUM BICARBONATE	Medical Purchasing Solutions, LLC	bfc9c321-665c-ca97-e053-2995a90a7954	2021-04-12	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Good Sense Omeprazole and Sodium Bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	L. Perrigo Company	bcf32242-de17-4da1-b707-4ce26262eb78	2020-11-16	Warnings	Exact identifier unii: 8MDF5V39QO
SODIUM BICARBONATE	SODIUM BICARBONATE	Aphena Pharma Solutions - Tennessee, LLC	15605a6d-6c90-47d5-9d1f-f66a3f27d5fc	2017-12-13	Warnings	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	Richmond Pharmaceuticals, Inc.	e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce	2017-11-01	Warnings	Exact identifier unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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