NDC Code(s) : 67457-658-10, 67457-657-25
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

esmolol hydrochloride in sodium chlorideesmolol hydrochloride in sodium chloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-658
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESMOLOL HYDROCHLORIDE(UNII: V05260LC8D)
(ESMOLOL - UNII:MDY902UXSR) 		ESMOLOL HYDROCHLORIDE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)4.1 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM ACETATE(UNII: 4550K0SC9B)2.8 mg in 1 mL
ACETIC ACID(UNII: Q40Q9N063P)0.546 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-658-101 in 1 POUCH 09/04/2018
1100 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206608 09/04/2018
esmolol hydrochloride in sodium chlorideesmolol hydrochloride in sodium chloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-657
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 CHLORIDE(UNII: 451W47IQ8X)5.9 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM ACETATE(UNII: 4550K0SC9B)2.8 mg in 1 mL
ACETIC ACID(UNII: Q40Q9N063P)0.546 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-657-251 in 1 POUCH 09/04/2018
1250 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206608 09/04/2018

LABELER - Mylan Institutional LLC(790384502)

PRINCIPAL DISPLAY PANEL

NDC 67457-657-25

250 mL

Esmolol Hydrochloride in Sodium Chloride Injection

2500 mg/250 mL (10 mg/mL)

(Single-Dose Plastic Bag)

Iso-Osmotic

No Preservative Added

Single Intravenous Use Only

Rx only

Mylan

250 mL Pouch

PRINCIPAL DISPLAY PANEL

NDC 67457-658-10

100 mL

Esmolol Hydrochloride in Sodium Chloride Injection

2000 mg/100 mL (20 mg/mL)

(Single-Dose Plastic Bag)

Iso-Osmotic

No Preservative Added

Single Intravenous Use Only

Mylan

Rx only

100 mL Pouch