NDC 43066-555

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Dexmedetomidine Hydrochloride.

• Product ID: 43066-555_1abf8109-4d0f-4116-aa10-33cc4a4c3484
• NDC: 43066-555
• Product Type: Human Prescription Drug
• Proprietary Name: DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
• Generic Name: Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-08-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208532
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: DEXMEDETOMIDINE HYDROCHLORIDE
• Active Ingredient Strength: 200 ug/50mL
• Pharm Classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 43066-555-24

24 BAG in 1 CARTON (43066-555-24) > 50 mL in 1 BAG

• Marketing Start Date: 2019-08-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43066-555-24 [43066055524]

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION

• Marketing Category: ANDA
• Application Number: ANDA208532
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-27

Drug Details

Active Ingredients

Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	200 ug/50mL

OpenFDA Data

• SPL SET ID: aea9a3ad-c244-42be-9cd3-5df83fe2b522
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • 1018WH7F9I
• RxNorm Concept Unique ID - RxCUI:
  • 1718909
  • 1718906

Pharmacological Class

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

NDC Crossover Matching brand name "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE" or generic name "Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride"

NDC	Brand Name	Generic Name
0781-3493	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
0781-3494	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
0781-3495	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
43066-555	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride
43066-557	DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride
55150-296	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
55150-297	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride