NDC 0404-9938

PRECEDEX

Dexmedetomidine Hydrochloride

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

Product ID0404-9938_20e87c4b-96ca-4b67-b684-85175d00962b
NDC0404-9938
Product TypeHuman Prescription Drug
Proprietary NamePRECEDEX
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-01-13
Marketing CategoryNDA /
Application NumberNDA021038
Labeler NameHenry Schein, Inc.
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredient Strength100 ug/mL
Pharm ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0404-9938-02

1 VIAL in 1 BAG (0404-9938-02) > 2 mL in 1 VIAL
Marketing Start Date2022-01-13
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0404-9938PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDE
0409-0155PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1174PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1434PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1454PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1638PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
0409-1660PrecedexDEXMEDETOMIDINE HYDROCHLORIDE
52584-638PRECEDEXPRECEDEX
0143-9525Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0143-9526Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE

Trademark Results [PRECEDEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRECEDEX
PRECEDEX
75383541 2419482 Live/Registered
Orion Corporation
1997-11-03
PRECEDEX
PRECEDEX
75197776 not registered Dead/Abandoned
Orion Corporation
1996-11-13

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