NDC 0143-9526

Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

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

Product ID0143-9526_93c28c54-08b4-4cda-b4a8-27aeacd4767a
NDC0143-9526
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine Hydrochloride
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-30
Marketing CategoryANDA / ANDA
Application NumberANDA206407
Labeler NameHikma Pharmaceuticals USA 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 0143-9526-10

10 POUCH in 1 CASE (0143-9526-10) > 1 BAG in 1 POUCH > 50 mL in 1 BAG
Marketing Start Date2020-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9526-10 [00143952610]

Dexmedetomidine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206407
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-30

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0143-9525Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0143-9526Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
68382-124DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
70771-1319DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
71872-7122Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
0781-3297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
16729-239Dexmedetomidine hydrochlorideDexmedetomidine hydrochloride
16729-432Dexmedetomidine hydrochlorideDexmedetomidine hydrochloride
42023-146Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
44567-601Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
44567-603Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
45963-906Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
44567-600Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
44567-602Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
55150-209Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
57664-596Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
57884-3091DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
63323-421Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
67457-251Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
63323-671Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
71225-126DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
71872-7030Dexmedetomidine hydrochlorideDexmedetomidine hydrochloride
71872-7031Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
67457-925DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
43066-565DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
43066-561DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
67457-924DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
43598-975DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
70121-1388Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
70121-1389Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
55150-297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
68083-238Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride
43598-976DEXMEDETOMIDINE 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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