NDC 51224-115

Dexmedetomidine Hydrochloride in Sodium Chloride

Dexmedetomidine Hydrochloride

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

Product ID51224-115_8ad221a8-a920-4ecc-8d80-b842144eff31
NDC51224-115
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine Hydrochloride in Sodium Chloride
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-11-23
Marketing CategoryANDA / ANDA
Application NumberANDA212857
Labeler NameTAGI Pharma, Inc.
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredient Strength4 ug/mL
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51224-115-20

20 BOTTLE in 1 CARTON (51224-115-20) > 50 mL in 1 BOTTLE (51224-115-01)
Marketing Start Date2020-11-23
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Dexmedetomidine Hydrochloride in Sodium Chloride" or generic name "Dexmedetomidine Hydrochloride"

NDCBrand NameGeneric Name
51224-115Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine Hydrochloride in Sodium Chloride
68094-147Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine Hydrochloride in Sodium Chloride
68094-247Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine Hydrochloride in Sodium Chloride
51224-015Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine Hydrochloride in Sodium Chloride
51224-215Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine Hydrochloride in Sodium Chloride
68094-047Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine Hydrochloride in Sodium Chloride
0143-9525Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0143-9526Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
0404-9938PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDE
0409-0155PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1174PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1434PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1454PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1638PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1660PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
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