NDC 71225-126

DEXMEDETOMIDINE HYDROCHLORIDE

Dexmedetomidine Hydrochloride

DEXMEDETOMIDINE HYDROCHLORIDE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Slayback Pharma Llc. The primary component is Dexmedetomidine Hydrochloride.

Product ID71225-126_0b74681f-0409-40ce-b4e4-ad90deaba277
NDC71225-126
Product TypeHuman Prescription Drug
Proprietary NameDEXMEDETOMIDINE HYDROCHLORIDE
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA212791
Labeler NameSlayback Pharma LLC
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 Through2020-12-31

Packaging

NDC 71225-126-04

10 VIAL in 1 CARTON (71225-126-04) > 20 mL in 1 VIAL (71225-126-01)
Marketing Start Date2021-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71225-126-02 [71225012602]

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA212791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-06

NDC 71225-126-03 [71225012603]

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA212791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-06

NDC 71225-126-01 [71225012601]

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA212791
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

NDC 71225-126-06 [71225012606]

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA212791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-06

NDC 71225-126-05 [71225012605]

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA212791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-06

Drug Details

Active Ingredients

IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

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 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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