NDC 67457-657

esmolol hydrochloride in sodium chloride

Esmolol Hydrochloride In Sodium Chloride

esmolol hydrochloride in sodium chloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Esmolol Hydrochloride.

• Product ID: 67457-657_08eb56ec-0d17-45a5-a0a9-9741b1d14909
• NDC: 67457-657
• Product Type: Human Prescription Drug
• Proprietary Name: esmolol hydrochloride in sodium chloride
• Generic Name: Esmolol Hydrochloride In Sodium Chloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-09-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206608
• Labeler Name: Mylan Institutional LLC
• Substance Name: ESMOLOL HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67457-657-25

1 BAG in 1 POUCH (67457-657-25) > 250 mL in 1 BAG

• Marketing Start Date: 2018-09-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-657-25 [67457065725]

esmolol hydrochloride in sodium chloride INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206608
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-04

Drug Details

Active Ingredients

Ingredient	Strength
ESMOLOL HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 01ad7942-99c3-40ee-9cfb-272fb6c44e2b
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • V05260LC8D
• RxNorm Concept Unique ID - RxCUI:
  • 979432
  • 1736541

Pharmacological Class

• Adrenergic beta-Antagonists [MoA]
• beta-Adrenergic Blocker [EPC]
• Adrenergic beta-Antagonists [MoA]
• beta-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "esmolol hydrochloride in sodium chloride" or generic name "Esmolol Hydrochloride In Sodium Chloride"

NDC	Brand Name	Generic Name
67457-657	esmolol hydrochloride in sodium chloride	esmolol hydrochloride in sodium chloride
67457-658	esmolol hydrochloride in sodium chloride	esmolol hydrochloride in sodium chloride
55150-420	esmolol hydrochloride	esmolol hydrochloride in sodium chloride
55150-421	esmolol hydrochloride	esmolol hydrochloride in sodium chloride
70121-1716	Esmolol Hydrochloride	Esmolol Hydrochloride in Sodium Chloride
70121-1717	Esmolol Hydrochloride	Esmolol Hydrochloride in Sodium Chloride