NDC 0143-9532

Dexmedetomidine HCl

Dexmedetomidine Hcl

Dexmedetomidine HCl is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Dexmedetomidine Hydrochloride.

• Product ID: 0143-9532_4ba7f37e-37cc-4882-8a20-a28d9404f947
• NDC: 0143-9532
• Product Type: Human Prescription Drug
• Proprietary Name: Dexmedetomidine HCl
• Generic Name: Dexmedetomidine Hcl
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-04-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205046
• Labeler Name: West-Ward Pharmaceuticals Corp
• 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: 2020-12-31

Packaging

NDC 0143-9532-25

25 VIAL in 1 CARTON (0143-9532-25) > 2 mL in 1 VIAL (0143-9532-01)

• Marketing Start Date: 2017-04-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0143-9532-01 [00143953201]

Dexmedetomidine HCl INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205046
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-04-26

NDC 0143-9532-25 [00143953225]

Dexmedetomidine HCl INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205046
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-04-26

Drug Details

Active Ingredients

Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	100 ug/mL

OpenFDA Data

• SPL SET ID: de6f01a2-9f2d-4c68-9c02-06643704acb1
• Manufacturer:
  • West-Ward Pharmaceuticals Corp
• UNII:
  • 1018WH7F9I
• RxNorm Concept Unique ID - RxCUI:
  • 309710

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0143-9532	Dexmedetomidine HCl	Dexmedetomidine HCl
71872-7218	Dexmedetomidine HCl	Dexmedetomidine HCl