NDC 68083-235-01 - Etomidate

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: 68083-235
Requested NDC: 68083-235-01
Package NDCs from labels: 68083-235-01, 68083-235-10
Manufacturer: Gland Pharma Limited
Effective date: 2017-10-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Etomidate Injection - Gland Pharma Limited	Gland Pharma Limited	2017-10-17	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-235-01	Etomidate	20 mL in 1 VIAL	SOLUTION	20		5
68083-235-10	Etomidate	10 in 1 CARTON	SOLUTION	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-235	ETOMIDATE (ETOMIDATE INJECTION) SOLUTION [GLAND PHARMA LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20171018_94cde4e7-3b46-419f-8dda-87675da8d89d.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 13 of 14 · 262 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
ETOMIDATE	ETOMIDATE	HF Acquisition Co LLC, DBA HealthFirst	dc43b289-4f32-1c1e-e053-2995a90a3a23	2022-04-09	Warnings, Adverse reactions	Exact identifier rxcui: 1654008 unii: Z22628B598
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Etomidate	ETOMIDATE INJECTION	Fosun Pharma USA Inc	8b6c54d8-3f3f-4290-841c-976bea01086f	2019-07-28	Warnings, Adverse reactions	Exact identifier application number: ANDA209058 rxcui: 1654006 rxcui: 1654008 unii: Z22628B598
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Etomidate	ETOMIDATE INJECTION	Gland Pharma Limited	94cde4e7-3b46-419f-8dda-87675da8d89d	2017-10-17	Warnings, Adverse reactions	Exact identifier application number: ANDA209058 ndc (package): 68083-235-01 ndc (package): 68083-234-01 ndc (package): 68083-235-10 ndc (package): 68083-234-10 ndc (product): 68083-235 ndc (product): 68083-234 ndc11 (package): 68083023501 rxcui: 1654006 rxcui: 1654008 spl id: 3e4fa967-6ab9-4de0-af94-f9c479504b20 spl set id: 94cde4e7-3b46-419f-8dda-87675da8d89d unii: Z22628B598
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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