NDC 0409-1660

Precedex

Dexmedetomidine Hydrochloride

Precedex is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Dexmedetomidine Hydrochloride.

• Product ID: 0409-1660_2846e0a6-76ab-4f5a-989f-105ea390809c
• NDC: 0409-1660
• Product Type: Human Prescription Drug
• Proprietary Name: Precedex
• Generic Name: Dexmedetomidine Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-04-08
• Marketing Category: NDA / NDA
• Application Number: NDA021038
• Labeler Name: Hospira, Inc.
• Substance Name: DEXMEDETOMIDINE HYDROCHLORIDE
• Active Ingredient Strength: 4 ug/mL
• Pharm Classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0409-1660-10

10 BOTTLE in 1 TRAY (0409-1660-10) > 100 mL in 1 BOTTLE (0409-1660-35)

• Marketing Start Date: 2013-04-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-1660-20 [00409166020]

Precedex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-05

NDC 0409-1660-10 [00409166010]

Precedex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-08

NDC 0409-1660-22 [00409166022]

Precedex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-18

NDC 0409-1660-50 [00409166050]

Precedex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-08

NDC 0409-1660-35 [00409166035]

Precedex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-18

NDC 0409-1660-55 [00409166055]

Precedex INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-18

Drug Details

Active Ingredients

Ingredient	Strength
DEXMEDETOMIDINE HYDROCHLORIDE	4 ug/mL

OpenFDA Data

• SPL SET ID: 548a88c0-afda-427e-75ac-5af0cfa2224c
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 1018WH7F9I
• RxNorm Concept Unique ID - RxCUI:
  • 1718910
  • 309710
  • 1718902
  • 1718900
  • 1718907
  • 1718906
  • 284397
  • 1718909

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE
0409-0155	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE
0409-1454	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE
52584-638	PRECEDEX	PRECEDEX
0143-9525	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride
0143-9526	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride
0338-9555	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE
0338-9557	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE