Etomidate (Page 3 of 3)

HOW SUPPLIED

Etomidate Injection, USP 2 mg/ mL is a sterile, nonpyrogenic clear colorless solution supplied in single-dose vials as follows:

NDC No. Etomidate Injection, USP (2 mg/mL) Package Factor
65145-127-10 20 mg/10 mL (2 mg/mL) Single-Dose Vial 10 vials per carton
65145-128-10 40 mg/20 mL (2 mg/mL) Single-Dose Vial 10 vials per carton

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]

ANIMAL PHARMACOLOGY & OR TOXICOLOGY


Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans.
In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data (See WARNINGS/Pediatric Neurotoxicity, PRECAUTIONS/Pregnancy, Pediatric Use).
Manufactured by:
Caplin Steriles Limited,
Gummidipoondi – 601 201,
India.
Code: TN/Drugs/TN00003457

August, 2020
CSL/AWC/XXX-XX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Etomidate Injection, USP 20 mg/10 mL (2 mg/mL)

NDC 65145-127-01

Rx only
For Intravenous Use Only
10 mL Single-Dose Vial

etomidate-spl-vial-10ml
(click image for full-size original)

Etomidate Injection 10 mL Carton

NDC 65145-127-10

10 X 10 mL Single-dose Vial

etomidate-spl-carton-10ml
(click image for full-size original)

Etomidate Injection, USP 4 0 mg/20 mL (2 mg/mL)

NDC 65145-128-01
Rx only
For Intravenous Use Only
20 mL Single-Dose Vial

etomidate-spl-vial-20ml
(click image for full-size original)

Etomidate Injection 20 mL Carton

NDC 65145-128-10

10 X 10 mL Single-dose Vial

etomidate-spl-carton-20ml
(click image for full-size original)
ETOMIDATE etomidate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65145-127
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETOMIDATE (ETOMIDATE) ETOMIDATE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65145-127-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (65145-127-01)
1 NDC:65145-127-01 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (65145-127-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215028 03/15/2021
ETOMIDATE etomidate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65145-128
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETOMIDATE (ETOMIDATE) ETOMIDATE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65145-128-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (65145-128-01)
1 NDC:65145-128-01 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (65145-128-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215028 03/15/2021
Labeler — Caplin Steriles Limited (650744670)
Establishment
Name Address ID/FEI Operations
Caplin Steriles Limited 650744670 ANALYSIS (65145-127), ANALYSIS (65145-128), MANUFACTURE (65145-127), MANUFACTURE (65145-128), PACK (65145-127), PACK (65145-128)

Revised: 12/2020 Caplin Steriles Limited

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