NDC Code(s) : 68083-211-01, 68083-211-25
Packager : Gland Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Esmolol Hydrochloride Esmolol Hydrochloride INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-211
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESMOLOL HYDROCHLORIDE(UNII: V05260LC8D)
(ESMOLOL - UNII:MDY902UXSR) 		ESMOLOL HYDROCHLORIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE(UNII: 4550K0SC9B)2.8 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)5.9 mg in 1 mL
ACETIC ACID(UNII: Q40Q9N063P)0.546 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-211-2525 in 1 CARTON 19/08/2019
1NDC:68083-211-0110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208538 08/19/2019

LABELER - Gland Pharma Limited(918601238)

Establishment
Name Address ID/FEI Business Operations
Gland Pharma Limited 918601238 ANALYSIS(68083-211), MANUFACTURE(68083-211), PACK(68083-211)

PRINCIPAL DISPLAY PANEL

NDC 68083-211-01

Esmolol Hydrochloride Injection

100 mg/10 mL
(10 mg/mL)

For Intravenous Use
 Iso-Osmotic
Contains no preservatives – discard unused portion
10 mL single dose vial
esmolol-spl-figure-1
NDC 68083-211-25
Esmolol Hydrochloride Injection
 100 mg/10 mL
(10 mg/mL)
 For Intravenous Use
 Iso-Osmotic
Contains no preservatives – discard unused portion
25 × 10 mL Single Dose Vials


esmolol-spl-figure-1