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
72485-508-10 20 mg/10 mL (2 mg/mL) Single-Dose Vial 10 vials per carton
72485-509-10 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).

Discard unused portion.

Distributed by:

Armas Pharmaceuticals, Inc.,

Freehold, NJ 07728 (USA)

Manufactured by:
Caplin Steriles Limited,
Gummidipoondi – 601 201, India.
Code: TN/Drugs/TN00003457

22200585

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Etomidate Injection — 10 mL Vial Label
NDC 72485-508-01

Rx only

Etomidate
Injection, USP
20 mg/10 mL
(2 mg/mL)
For Intravenous Use Only 10 mL Single-Dose Vial

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

Etomidate Injection — 10 mL Carton

NDC 72485-508-10

10 X 10 mL Single-dose Vial

Rx Only

Etomidate

Injection, USP

20 mg/10mL

(2mg/mL)

For Intravenous Use Only

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

Etomidate Injection — 20 mL Vial Label

NDC 72485-509-01

Rx only

Etomidate
Injection, USP
4 0 mg/20 mL
(2 mg/mL)
For Intravenous Use Only 20 mL Single-Dose Vial

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

Etomidate Injection — 20 mL Carton

NDC 72485-509-10

10 X 20 mL Single-dose Vial

Rx Only

Etomidate

Injection, USP

40 mg/20mL

(2mg/mL)

For Intravenous Use Only

20ml-carton
(click image for full-size original)
ETOMIDATE etomidate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72485-508
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:72485-508-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (72485-508-01)
1 NDC:72485-508-01 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72485-508-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215028 01/22/2024
ETOMIDATE etomidate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72485-509
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:72485-509-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (72485-509-01)
1 NDC:72485-509-01 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72485-509-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215028 01/22/2024
Labeler — Armas Pharmaceuticals Inc. (098405973)
Registrant — Armas Pharmaceuticals Inc. (098405973)
Establishment
Name Address ID/FEI Operations
Caplin Steriles Limited 650744670 ANALYSIS (72485-508), ANALYSIS (72485-509), MANUFACTURE (72485-508), MANUFACTURE (72485-509), PACK (72485-508), PACK (72485-509)

Revised: 01/2024 Armas Pharmaceuticals Inc.

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