NDC 67457-251

Dexmedetomidine

Dexmedetomidine

Dexmedetomidine is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Dexmedetomidine Hydrochloride.

• Product ID: 67457-251_0139b0bb-7409-4d68-aaf9-add9f3408439
• NDC: 67457-251
• Product Type: Human Prescription Drug
• Proprietary Name: Dexmedetomidine
• Generic Name: Dexmedetomidine
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-08-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202881
• Labeler Name: Mylan Institutional LLC
• Substance Name: DEXMEDETOMIDINE HYDROCHLORIDE
• Active Ingredient Strength: 100 ug/mL
• Pharm Classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 67457-251-02

25 VIAL, GLASS in 1 CARTON (67457-251-02) > 2 mL in 1 VIAL, GLASS (67457-251-00)

• Marketing Start Date: 2014-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-251-00 [67457025100]

Dexmedetomidine INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA202881
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-18

NDC 67457-251-02 [67457025102]

Dexmedetomidine INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA202881
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-18

Drug Details

Active Ingredients

Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	100 ug/mL

OpenFDA Data

• SPL SET ID: ebdfe2e8-30ca-4f18-935a-41bcbbce4937
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 1018WH7F9I
• RxNorm Concept Unique ID - RxCUI:
  • 309710

Pharmacological Class

• Adrenergic alpha2-Agonists [MoA]
• Central alpha-2 Adrenergic Agonist [EPC]
• General Anesthesia [PE]

NDC Crossover Matching brand name "Dexmedetomidine" or generic name "Dexmedetomidine"

NDC	Brand Name	Generic Name
16729-239	Dexmedetomidine	Dexmedetomidine
16729-432	DEXMEDETOMIDINE	DEXMEDETOMIDINE
17478-055	Dexmedetomidine	Dexmedetomidine Hydrochloride
55150-209	Dexmedetomidine	Dexmedetomidine
57884-3091	DEXMEDETOMIDINE	DEXMEDETOMIDINE
66794-230	Dexmedetomidine	Dexmedetomidine
66794-233	Dexmedetomidine	Dexmedetomidine
66794-238	Dexmedetomidine	Dexmedetomidine
67457-251	Dexmedetomidine	dexmedetomidine
70860-605	Dexmedetomidine	dexmedetomidine
71288-505	DEXMEDETOMIDINE	DEXMEDETOMIDINE
71872-7150	Dexmedetomidine	dexmedetomidine
81092-1120	IGALMI	DEXMEDETOMIDINE
81092-1180	IGALMI	DEXMEDETOMIDINE