NDC 70121-1389

Dexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride

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

Product ID70121-1389_45057437-7010-43b1-ac48-54b335bc768a
NDC70121-1389
Product TypeHuman Prescription Drug
Proprietary NameDexmedetomidine Hydrochloride
Generic NameDexmedetomidine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA207551
Labeler NameAmneal Pharmaceuticals 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 Through2024-12-31

Packaging

NDC 70121-1389-7

10 BOTTLE, GLASS in 1 CARTON (70121-1389-7) > 100 mL in 1 BOTTLE, GLASS (70121-1389-1)
Marketing Start Date2020-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70121-1389-7 [70121138907]

Dexmedetomidine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207551
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-20

NDC 70121-1389-1 [70121138901]

Dexmedetomidine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207551
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-20

Drug Details

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.