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 9 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Publix Fast Relief Effervescent	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Publix Super Markets Inc.	73051f16-2569-7394-e053-2991aa0a5359	2024-11-13	Warnings	Exact identifier unii: 8MDF5V39QO
Quality Choice Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	70d265de-ff94-e0e4-e053-2a91aa0a962a	2024-11-13	Warnings	Exact identifier unii: 8MDF5V39QO
Quality Choice Extra Strength Effervescent Antacid and Pain Relief	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	9f7d0c96-a561-a8a0-e053-2995a90a250b	2024-11-13	Warnings	Exact identifier unii: 8MDF5V39QO
WinCo Foods Effervescent Antacid and Pain Relief	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET	WinCo Foods, LLC	0c8a755a-089f-477f-97e9-0dd6fdfbe99d	2024-11-13	Warnings	Exact identifier unii: 8MDF5V39QO
Sodium Bicarbonate	SODIUM BICARBONATE	Cardinal Health 107, LLC	f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f	2024-11-07	Warnings	Exact identifier unii: 8MDF5V39QO
ertapenem sodium	ERTAPENEM SODIUM	Hikma Pharmaceuticals USA, Inc.	a400707f-763f-43f6-989e-0d2569d822d8	2024-11-06	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0
Ertapenem	ERTAPENEM	Hospira, Inc.	178a0356-4f6c-47fb-9913-f325a3c72f7b	2024-11-06	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0
Ertapenem	ERTAPENEM SODIUM	Hikma Pharmaceuticals USA Inc.	b88c0709-33fe-47db-8ae8-8bad6692d5d5	2024-11-05	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0
Sodium Bicarbonate	SODIUM BICARBONATE	Rising Pharma Holdings, Inc.	f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e	2024-11-01	Boxed warning, Warnings	Exact identifier unii: 8MDF5V39QO
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	ScieGen Pharmaceuticals, Inc.	a107804e-b308-4e79-9447-07d93016f70f	2024-10-24	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	53380470-5748-6fa7-548e-7484ef204c0f	2024-10-21	Warnings	Exact identifier unii: 8MDF5V39QO
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	8723fe90-8402-4511-b6c6-b71cf98513e3	2024-10-21	Warnings	Exact identifier unii: 8MDF5V39QO
Elliotts B	SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE	Lukare Medical, LLC	08036dbd-55b3-47b9-9890-000f253544f3	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
SODIUM BICARBONATE	SODIUM BICARBONATE INJECTION,	Long Grove Pharmaceuticals, LLC	a26d709b-b294-4b02-9a88-7e840f099a33	2024-09-25	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Insect sting relief latex 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b9e2d4c-bc0c-6ed0-e063-6294a90a9103	2024-08-19	Warnings	Exact identifier unii: 8MDF5V39QO
Quality Choice Effervescent Antacid and Pain Relief - Extra Strength	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	Chain Drug Marketing Association	1f926637-a61c-8eb7-e063-6394a90a6502	2024-08-13	Warnings	Exact identifier unii: 8MDF5V39QO
Omeprazole/Sodiium Bicarbonate	OMEPRAZOLE/SODIIUM BICARBONATE	Direct_rx	1f7f63c1-17c2-9a05-e063-6394a90abc6f	2024-08-12	Warnings, Adverse reactions	Exact identifier unii: 8MDF5V39QO
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	ddee28fb-c871-a6d4-984f-515522b28412	2024-07-15	Warnings	Exact identifier unii: 8MDF5V39QO
Ertapenem	ERTAPENEM	Eugia US LLC	f725a68c-31a2-482a-9744-19adc47506b5	2024-07-09	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0
Ertapenem	ERTAPENEM	Eugia US LLC	31bcf16f-e0c1-47d1-9852-de898a856f6e	2024-07-09	Warnings, Adverse reactions	Exact identifier rxcui: 1734683 unii: 2T90KE67L0

Reported adverse events (FAERS/openFDA)#

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